Insulin injection assistance systems, methods, and devices

ABSTRACT

One or more embodiments of the disclosure relate, generally, to a system to assist with manual dosing of insulin. Such a system may include a glucose sensor system, a reusable insulin dosing detector, and a recommendation system. The reusable insulin dosing detector may be configured to be reversibly connectable to a disposable component that may form part of an insulin manual delivery assembly. The reusable insulin dosing detector may be configured to detect insulin delivery associated with the insulin manual delivery assembly. The recommendation system may be configured to analyze blood glucose data and determine adjustments to insulin therapy settings.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional Patent Application Ser. No. 62/682,878, filed Jun. 9, 2018,for “Insulin Injection Assistance Systems, Methods, and Devices”; ofU.S. Provisional Patent Application Ser. No. 62/597,809 filed Dec. 12,2017, for “Medicine Injection and Disease Management Systems, Devices,and Methods”; of U.S. Provisional Patent Application Ser. No.62/597,868, filed Dec. 12, 2017, for “Therapy Assist Information and/orTracking Device and Related Methods and Systems”; and of U.S.Provisional Patent Application Ser. No. 62/628,808, filed Feb. 9, 2018,for “Diabetes Therapy Management Systems, Methods and Devices,” thedisclosure of each of which is hereby incorporated herein in itsentirety by this reference.

TECHNICAL FIELD

This disclosure relates to therapy management systems, methods, anddevices adapted to collect and/or transmit data relating to therapy(e.g., the timing of therapy) and/or other therapy related data and toprovide a user with therapy recommendations. In particular embodiments,diabetes therapy management systems, devices, and methods are disclosed,which may be utilized with insulin injection devices, includingcomponents adapted to provide a user with insulin therapyrecommendations based on stored therapy parameters, blood glucose data,meal size estimations, and/or other parameters.

BACKGROUND

Diabetes mellitus is a chronic metabolic disorder caused by theinability of a person's pancreas to produce sufficient amounts of thehormone insulin such that the person's metabolism is unable to providefor the proper absorption of sugar and starch. This failure leads tohyperglycemia, i.e., the presence of an excessive amount of glucosewithin the blood plasma. Persistent hyperglycemia has been associatedwith a variety of serious symptoms and life threatening long-termcomplications such as dehydration, ketoacidosis, diabetic coma,cardiovascular diseases, chronic renal failure, retinal damage and nervedamages with the risk of amputation of extremities. Because healing isnot yet possible, a permanent therapy is necessary which providesconstant glycemic control in order to constantly maintain the level ofblood analyte within normal limits. Such glycemic control is achieved byregularly supplying external drugs to the body of the patient to therebyreduce the elevated levels of blood analyte.

An external biologically effective drug (e.g., insulin or its analog) iscommonly administered by means of daily injections. In some cases,multiple, daily injections (MDI) of a mixture of rapid- and long-actinginsulin via a reusable transdermal liquid dosing device (commonlyreferred to as an “insulin pen”) or a hypodermic syringe. The injectionsare typically administered by a person with diabetes (PWD), and sorequire self-monitoring of blood glucose and the self-administration ofinsulin. The PWD that manages their care using MDI often plans insulininjections for each day, in advance, based on basal insulin requirementas well as external factors such as meals, exercise, sleep, etc. Atypical dosing plan will include the time of day for an injection, thetype of insulin (e.g., fast acting, long acting, a mixture of fastacting and long acting, etc.), and amount of insulin for each dose. Inaddition, PWDs will self-monitor their blood glucose and self-administer“bolus” dose(s) of rapid-acting insulin if their blood glucose is toohigh or consume carbohydrates (or sometimes administer glycogen) iftheir blood glucose is too low.

The “correct” insulin dose is a function of the level of glucose in theblood, physiological factors such as a person's insulin sensitivity, andlifestyle factors such as meals (e.g., recently consumed carbohydratesthat have yet to be metabolized into glucose and absorbed into theblood). Moreover, even with careful planning and self-monitoring, a PWDmay skip doses, double dose, and dose the wrong amount and/or type ofinsulin. Insufficient insulin can result in hyperglycemia, and too muchinsulin can result in hypoglycemia, which can result in clumsiness,trouble talking, confusion, loss of consciousness, seizures, or death.Accordingly, PWDs face a considerable cognitive burden in determiningappropriate doses of insulin.

In order to assist with self-treatment, some diabetes treatment devices(e.g., blood glucose meters, insulin pumps, etc.) are equipped withinsulin bolus calculators that have the user input an estimate (e.g.,numerical estimate) of the quantity of carbohydrates consumed or aboutto be consumed (or additionally or alternatively protein, fat, or othermeal data) and the bolus calculator outputs a recommended size for theinsulin bolus dosage. Although bolus calculators remove some of themental calculations that need to be made by the user in determining anappropriate insulin bolus dosage, bolus calculators still burden theuser with the mental task of evaluating the constituents of their meal,may require the use of a secondary device, and often require manualentry of data. Accordingly, there is a need for methods, systems, anddevices that assist the user to make appropriate therapy decisions whileminimizing the burdens (e.g., data entry, mental calculations,procedures, etc.) on the user.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure may be understood more fully by reference to thefollowing detailed description of example embodiments, which areillustrated in the accompanying figures.

FIG. 1A illustrates a diabetes management system according toembodiments of the present disclosure. FIG. 1B illustrates the specificcomponents of an exemplary diabetes management system. FIG. 1Cillustrates a second exemplary diabetes management system.

FIG. 2 illustrates a user utilizing one or more portions of a diabetesmanagement system according to embodiments of the present disclosure.

FIGS. 3 through 6 illustrate displays on pen caps according toembodiments of the present disclosure.

FIG. 7 illustrates example communications architecture for a systemaccording to embodiments of the present disclosure.

FIG. 8 illustrates a process for recommending an insulin dose accordingto an embodiment of the disclosure.

FIG. 9 illustrates a process for injecting insulin according to anembodiment of the disclosure.

FIG. 10 illustrates a process for recommending an insulin dose accordingto an embodiment of the disclosure.

FIG. 11 illustrates a process for injecting insulin according to anembodiment of the disclosure.

FIG. 12 illustrates a process for checking the status of a therapysystem according to an embodiment of the disclosure.

FIG. 13 illustrates a process for checking the status of a therapysystem according to an embodiment of the disclosure.

FIG. 14 illustrates a process for updating therapy information accordingto an embodiment of the disclosure.

FIG. 15 illustrates a process for checking the status of a therapysystem according to an embodiment of the disclosure.

FIGS. 16 through 25 illustrate example displays and/or user interfacesof a portion of the system (e.g., of the mobile device) according toembodiments of the present disclosure.

FIG. 26 depicts an example sliding scale chart of a diabetes managementsystem according to embodiments of the present disclosure.

FIGS. 27 through 33 illustrate example displays and/or user interfacesof a portion of the system (e.g., of the mobile device) according toembodiments of the present disclosure.

FIGS. 34A-34D illustrate example communications architectures for anupgradable system according to embodiments of the present disclosure.

FIGS. 35A and 35B illustrate exemplary displays on pen caps according toembodiments of the present disclosure.

DETAILED DESCRIPTION

Manual insulin delivery devices such as insulin pens, insulin inhalers,etc. (referred to herein, generally, as “manual insulin devices”)provide a convenient, reusable means of delivering insulin. The improperdosing of insulin, however, due to human error, malfunction of aninsulin pen, skipping doses, double dosing, and incorrect dosing, isalways a concern. Although methods, devices, and systems provided hereinare described for the delivery of insulin, collection of blood glucosedata, and/or the treatment of diabetes, methods, devices, and systemsprovided herein may be adapted for the delivery of other medications,the collection of other analyte data, and/or the treatment of otherdiseases. Additionally, although methods, devices, and systems providedherein are described primarily by describing features andfunctionalities included in pen cap accessory for insulin delivery pensor methods the use pen cap accessories, or systems including pen capaccessories, the features discussed herein are also contemplated asbeing incorporated directly into smart medication delivery pens or smartmedication delivery inhalers, other accessories adapted to be secured toor used with other manual medication delivery devices, or methods orsystems including such smart medication delivery devices or smartaccessories.

Systems, devices, and methods described herein may be operated orperformed, respectively, by a user for example, a PWD, a patient, a testsubject, a healthcare professional, clinician and a caregiver. Unlessotherwise stated, the terms health care professional, clinician, and acaregiver are used interchangeably in this disclosure.

In general, the embodiments of therapy management systems (e.g.,diabetes management systems such as insulin therapy management systems),methods, and devices described herein may include user interfacesconfigured to receive user-specific dosage parameters from a user orhealthcare professional and use those user-specific dosage parameters toprovide recommendations and reports to a user. In some embodiments, auser interface for receiving user-specific dosage parameters may beincorporated into a mobile application or another computing device and auser interface for displaying an immediate medication deliveryrecommendation may be incorporated into an accessory for a manualmedication delivery device or a smart manual medication delivery device.In some cases, a user interface for entering user-specific dosageparameters can additionally be used for viewing reports,recommendations, alarms, alerts, notifications, recommended user-dosageparameter changes.

Systems, devices, and methods provided herein can include a userinterface that is adapted to simplify the entry of therapy relevant datato ease the burden of self-treatment. In some embodiments, systems,devices, and methods provided herein are adapted to assist a person withdiabetes (PWD) or their caregiver in determining an appropriate dosageof insulin. In some embodiments, methods, devices, and systems providedherein can reduce or eliminate the manual entry of numerical data afteran initial setup. In some embodiments, methods, devices, and systemsprovided herein may be adapted to simplify the monitoring of bloodglucose levels. In some embodiments, methods, devices, and systemsprovided herein can permit a user to discreetly manage their therapy. Insome embodiments, methods, devices, and systems provided herein canreduce the cognitive burden associated with making daily therapydecisions.

Systems, devices and methods provided herein can simplify the processfor obtaining insulin therapy suggestions and/or simplifying thecollection of estimated glucose values (EGVs) and/or insulin deliverydata from one or more insulin delivery devices. Systems, devices, andmethods provided herein may be designed to minimize the changes thatpersons with diabetes (PWDs) that administer insulin therapy usinginjections may be required to make to their therapy/daily routines inorder to receive therapy recommendations and/or to receivenotifications, alerts, or alarms.

In some embodiments, systems, methods, and devices provided herein cangive a user options of when, where, and whether to receivenotifications, alerts or alarms, which may be, at least in part, basedupon the devices of the system being carried by the user. In someembodiments, the alarms and/or alerts may be customized over time basedon feedback from the user (e.g., likes and dislikes from the user). Insome embodiments, systems, methods, and devices provided herein caninclude notifications, alerts, and/or alarms that use a combination ofEGV data and insulin delivery data to determine whether to trigger thenotification, alert, and/or alarm.

In some embodiments, systems, devices, and methods provided herein canautomatically capture insulin delivery data, which may be captured usinga connected and/or smart insulin injection pen or a connected and/orsmart insulin pen accessory (e.g., a connected pen cap accessory).

In some embodiments, systems, devices, and methods provided herein canrecommend insulin doses (e.g., dosages of long-acting and/orrapid-acting insulin) using any suitable technique. In some embodiments,recommended insulin dosages may be based upon blood glucose data (e.g.,current EGV from continuous glucose monitor (“CGM”), flash glucosemonitor, blood glucose meter, or any other sensor, blood glucose trenddata, etc.), insulin administration data (bolus dosage amounts ofrapid-acting insulin, dosages of long-acting insulin, dosage times,calculation of Insulin-on-Board (“IOB”) and/or active insulin, etc.),meal data (mealtimes, user estimated carbohydrates, user estimated mealcategorizations, user estimated glycemic impact of meal user mealhistory, user meal trends, etc.), and/or one or more insulin deliverparameters total daily dose of basal insulin or long-acting insulin,carbohydrate-to-insulin ratio (CR), insulin sensitivity factor (ISF),etc.). Methods, devices and systems provided herein can, in someembodiments, adjust insulin delivery parameters over time based onglucose data and/or insulin administration data.

Systems, devices, and methods provided herein can include or use amobile device (e.g., a mobile application running on a smartphone ortablet) to permit the user to setup the device or system, to checkstatus of the device or system, adjust therapy settings, and/or learnabout how to improve their therapy choices. In some embodiments, amobile device can include information about maintenance tasks (e.g.,reminders to conduct certain maintenance tasks). In some embodiments,methods, systems, and devices provided herein can detect patterns intherapy relevant data and use that data to provide a user with tips,suggestions, alerts, and/or alarms based on the patterns, which may bedisplayed on a mobile device. In some embodiments, a mobile device mayprovide a user with graphical displays regarding the user's therapyrelevant data and/or therapy decisions (e.g., blood glucose data and/orinsulin injection times). In some embodiments, a mobile device mayprovide a user with an indication that the user might want to adjusttheir therapy (e.g., an amount of insulin for meals, an amount ofinsulin for the user's basal requirements, a timing of their insulininjections, etc.) and provide the user with a mechanism (e.g., a link)to make adjustments to their therapy. In some embodiments, a mobiledevice may provide a user with an indication that the system hasautomatically adjusted their therapy (e.g., an amount of insulin formeals, an amount of insulin for the user's basal requirements, a timingof their insulin injections, etc.) and optionally provide the user witha mechanism (e.g., a link) to reject the automatic adjustment, confirmthe automatic adjustment, or make a manual therapy adjustment.

In some embodiments, diabetes management systems, devices, and methodsprovided herein can include a plurality of meal size categories (e.g.,three meal sizes (Small, Medium, Large), time-based meals (Breakfast,Lunch, Dinner, Snack)) that may be set by the user (e.g., on a mobiledevice). In some embodiments, a mobile device includes a setup userinterface where a user is prompted to enter the user's typical insulindosage for differently sized meals (e.g., a dose for a small meal, adose for a medium meal, a dose for a large meal). In some embodiments,the setup user interface displays to the user example pictures of mealsthat would be considered to be within each meal category. In someembodiments, the device may analyze the approximate size of the meal forthe user (e.g., by analyzing an input from the user, such as an inputrelating to characteristics of the meal, a picture of the meal, etc.).In some embodiments, the setup user interface may provide estimates ofwhat the user is expected to enter for each meal size based on theuser's entered amount of long-acting insulin (e.g., dosage of LANTUS®).

Systems, devices, and methods provided herein can include, use, orcommunicate with one or more accessories for a medication deliverydevice, such as an insulin pen (e.g., a pen cap for the insulin pen)that is (a) adapted to be secured to an injection pen and detect whenthe pen cap is secured to and/or released from the injection pen, (b)adapted to receive blood glucose data from a glucose sensor, and/or (c)adapted to provide therapy relevant information and/or recommendationsto the user.

In some cases, the accessory may be a pen cap accessory adapted todetect pen capping information. Pen capping information (e.g.,information about when the pen cap is secured to and/or released fromthe injection pen) can include information about a current cappingperiod (e.g., the time since the last capping), information about aduration of one or more uncappings (which may also be referred to hereinas “decapping(s)”), and the timing (e.g., time-of-day or time elapsedsince) of each uncapping and each capping. In some embodiments, pencapping information may be displayed on the pen cap accessory to a user.In some embodiments, pen capping information may be announced by aspeaker in the pen cap. For example, in some embodiments, a pen cap mayprovide a timer clock that counts up from the last time the pen cap wassecured to the injection pen. In some embodiments, a pen cap accessorycan wirelessly communicate pen capping information to a remote computingdevice (e.g., a smartphone, tablet, etc.). In some embodiments that donot include pen cap accessories, the accessories or smart deliverydevices can detect other events associated with medication deliveryactions and use that information in ways that pen capping information isdescribed herein. For example, in some cases an injection pen accessorymay be secured to an injection pen such that it can detect themechanical movement of the dosing mechanism to determine a time of adose of medication.

Pen capping information may be used to modify the user experience (e.g.,the display or information presented to the user). In some embodiments,the pen cap adjusts the presentation of the therapy relevant informationand/or recommendations provided to the user based on the pen cappinginformation. For example, in some embodiments, a pen cap may providebolus recommendations to correct for elevated blood glucose levels basedon data from a glucose sensor, but may limit the presentation of suchcorrection bolus recommendations to time periods when the current pencapping duration is greater than a threshold period of time (e.g., atleast 2 hours, at least 3 hours, at least 4 hours, or at least 5 hours).In some embodiments, the pen cap may provide notifications, alerts, oralarms to the user based on the pen capping information. For example, ifthe pen cap is removed from the injection pen within a threshold periodof time (e.g., within 30 minutes or 1 hour) from a previous capping, thepen cap may provide a visual, audible, or vibrational notification toindicate that the user may have recently used the pen to administerinsulin. In some embodiments, the pen cap may be in wirelesscommunication with a mobile computing device (e.g., a smartphone,tablet) and one or more notifications, alerts, or alarms based on pencapping information may be announced or displayed on the mobilecomputing device.

Pen capping information may be stored, displayed, and/or analyzed incombination with glucose data to determine user behaviors, such as, forexample, whether the person is appropriately dosing insulin for mealsand/or to correct elevated blood glucose levels. In some embodiments,pen capping information may be presented on a graphical representationof blood glucose data for the user and presented to a user and/or to ahealthcare professional. In some embodiments, blood glucose data from aperiod of time after each capping event may be evaluated to determinewhether the user appropriately dosed insulin for that capping event,e.g., appropriate dose, under dose, or over dose.

In some embodiments, a pen capping event may be disregarded where otherinformation indicates that a dose was not provided. For example, whereno change in the dosage selection of the insulin pen (e.g., a dial) wasdetected, the event may be disregarded. In some embodiments, a penuncapping and recapping event may be disregarded if the total uncappingtime is less than a first threshold (e.g., 4-6 seconds). For example,the threshold may be determined by setting it at an amount of time tooshort to permit for an injection, but long enough to allow a user tocheck the end of the pen to see if there is insulin remaining or ifthere is a needle attached to the pen. In some cases, the totaldecapping time (the time between an uncapping event and the subsequentrecapping) for a decapping event may be analyzed in combination withblood glucose data to determine if there was an injection during thatdecapping event. In some cases, if the total decapping time exceeds asecond threshold period of time (e.g., at least 15 minutes, at least 30minutes, etc.), blood glucose data may be used to determine anapproximate time of an injection.

Accessories provided herein (e.g., pen caps), and associated methods andsystems provided herein, may be adapted to obtain blood glucose data foruse in providing therapy relevant information and/or therapyrecommendations via the accessory (e.g., via a pen cap). In someembodiments, the therapy relevant information displayed on a pen capaccessory can include a current estimated glucose value (EGV) for theuser. In some embodiments, the therapy relevant information displayed onthe pen cap can include a current blood glucose trend or rate of changeindicator (e.g., a trend arrow). In some embodiments, the pen cap caninclude a recommended dose, which may be based on glucose data or may bebased on stored parameters without consideration of the current EGV.

Accessories provided herein (e.g. pen caps) may be adapted to receiveblood glucose data from any suitable glucose sensor. In someembodiments, the glucose sensor may be a continuous glucose monitor(CGM), a flash glucose monitor, a blood glucose meter (BGM), or anyother suitable sensor. In the case of CGMs and flash glucose monitor,they may be configured to provide glucose data based on interstitialfluid glucose levels of a user, which may be correlated to blood glucoselevels. A BGM may be configured to provide blood glucose data, typicallybased on a blood sample. Accordingly, while the term “blood glucose”may, at times, be used as a general term simply for convenience, thedisclosure is not limited to using just blood glucose data, values,levels, etc., but also interstitial fluid glucose levels, as well as anyintermediate measurement values.

In some embodiments, the pen cap may automatically receive glucose datafrom a CGM automatically without user action so long as the pen cap isin range. In some embodiments, the pen cap may be adapted to wirelesslyreceive current EGVs (and, optionally, prior EGVs) from a flash glucosemonitor when the pen cap is positioned in proximity to (e.g., swipedadjacent to) the flash glucose monitor. In some embodiments, EGVs may beobtained via a BGM, which may be in wireless communication with the pencap or a mobile computing device (which can then transmit the EGV to thepen cap) or may be entered by a user into a remote computing device.

Accessories provided herein (e.g., pen caps), in some embodiments, maybe configured to that they only retrieve glucose data upon a userinteracting with the pen cap. For example, if a pen cap is adapted toobtain glucose data from a CGM or flash glucose monitor, the pen cap maybe designed so that it needs to be swiped near the CGM or flash glucosemonitor or may be designed so that it can only retrieve glucose datawhen a demand is made by the user (e.g., when a button is pressed). Insome embodiments, a CGM may be in wireless communication with a mobilecomputing device (e.g., a smartphone, tablet) and data from the CGM onlytransferred to the pen cap when a button is pressed on the pen cap.

Accessories (e.g., pen caps) or mobile applications provided herein can,in some embodiments, provide reminders to a user to obtain glucose data.For example, in the case of methods and systems that include a flashglucose monitor, a reminder may be sent to the user to obtain glucosedata by swiping the pen cap near the flash glucose monitor. In someembodiments, reminders to obtain glucose data may be timed based on pencapping information. For example, a reminder to obtain blood glucosedata may be determined based on a time since the most recent capping(e.g., the current capping duration exceeding a threshold). In someembodiments, the threshold may be set to reduce the likelihood that adosage of insulin may cause a hypoglycemic event. In some embodiments, apen cap can wirelessly receive blood glucose data and analyze patternsof the blood glucose data in comparison to pen capping information todetermine a likelihood of a future hypoglycemic event or a predictedfuture blood glucose value. In some embodiments, blood glucose data andpen capping information may be wirelessly transmitted to a remotecomputing device (e.g., smartphone, tablet, etc.) and analyzed in thatremote computing device or in the cloud or other network or device todetermine a likelihood of a future hypoglycemic event or a predictedfuture blood glucose value, which may be used to issue a notification,alert, or alarm and/or to set a reminder to obtain blood glucose data.

Pen caps provided herein can use any suitable technique to obtain pencapping information (e.g., information relating to removal/applicationof the pen cap during an insulin injection). In some embodiments, pencaps provided herein can include a biasing element, such as, forexample, a leaf-spring on the inside of the cap that completes a circuitwhen the pen cap is secured to the injection pen. In other embodiments,the cap may include a sensor (e.g., an optical sensor, a mechanicalsensor, an electronic sensor, a magnetic sensor, etc.) that detects whenthe cap is applied to and/or removed from the pen.

Accessories (e.g., pen caps), methods, and systems provided herein canuse any suitable method for making therapy recommendations. In someembodiments, a user or healthcare professional can set recommendeddosage amounts for initiation of the product, set one or more initialcarbohydrate-to-insulin ratios, set one or more initial insulinsensitivity factors, create a table of correction doses to be used for aparticular range of glucose values, and/or set one or more mealcharacterizations. For example, in some embodiments a user or healthcareprofessional may set the initial recommended dose of long-acting insulinand a carbohydrate-to-insulin ratio and an insulin sensitivity factor tobe used in determining doses of rapid-acting insulin. In someembodiments, a user or healthcare professional may set typical mealsizes in carbohydrates for breakfast, lunch, and/or dinner. In someembodiments, a user or healthcare professional may set typicalmeal-based rapid-acting insulin doses for the user for breakfast, lunch,and dinner. In some embodiments, a user or healthcare professional mayset characterizations of differently sized meals (small (S), medium (M),large (L)) for different times of day (e.g., 10 g of carbohydrates forS, 25 g for M, and 50 g for L). In some embodiments, blood glucose dataand/or pen capping information may be analyzed to make adjustments to auser's dosage parameters and/or the meal-based dosage recommendations.In some embodiments, blood glucose data and/or pen capping informationmay be analyzed to make suggested changes to a user's dosage parametersand/or the meal-based dosage recommendations to a healthcareprofessional or to a user.

In some embodiments, accessories provided herein (e.g., pen caps) mayprovide meal-based bolus recommendations based on a time of day and/ormeal categories. For example, in some embodiments, the pen cap mayprovide different meal-based bolus recommendations based on it beingbreakfast time (e.g., about 8 am), lunch time (e.g., about noon), ordinner time (e.g., about 6 pm). In some embodiments, the pen cap mayprovide different meal-based bolus recommendations for different mealcategories, meal preferences, or historical meal statistics, such as,for example, small (S), medium (M), and large (L), which may be based onthe number of carbohydrates or the glycemic impact of a meal asestimated or determined by a user. For example, for each therapyrecommendation, a user may see a recommended meal-based bolus for a Smeal, for a M meal, and for a L meal. In some embodiments, a user maypress a button or user-selectable icon to request a recommendation for aS meal, for a M meal, or for a L meal. In some cases, the meal-basedbolus recommendations for each meal category (S, M, and L) can changebased on the time of day. In some embodiments, the meal-based bolusrecommendations for each meal category (S, M, and L) may change based ona historical evaluation of the user's meal sizes and/or consistency. Insome embodiments, a single display can indicate different suggestedinsulin dosages based on different meal characteristics and/or display arange of dosages based on the user's typical meal sizes (e.g.,customized to the user's meal sizes based on historical data), which maybe based on the time of the day, day of the week, day of the year,location of user, or any other collected data.

In some embodiments, a system provided herein can include one, two, ormore connected pen caps for insulin pens or other accessories for aninsulin pen (e.g., a connected dose-capture insulin pen cap), acontinuous glucose monitoring system (CGM) (or a flash glucosemonitoring system), a mobile application, an alert accessory, and/orcritical web services cloud software. In some embodiments, connectivityto the cloud-based server can enable the storage of data for use by thesystem when needed and transfer of information to other devices outsideof the system (e.g., optional secondary display of data, reports). Insome embodiments, components of systems provided herein may bewirelessly connected or can wirelessly connect using either BluetoothLow Energy (BLE), 433 MHZ ultra high frequency (UHF) radio, and/or anear-field communication (NFC) protocol.

One or more embodiments of the present disclosure may include an insulindelivery system that includes an insulin delivery device, a userinterface on the insulin delivery device or adapted to be secured(either releasably or non-releasably) to the insulin delivery device,memory to store one or more user-specific dosage parameters, and one ormore processors in communication with the memory and adapted to receiveblood glucose data, determine a recommended insulin dosage, and/ordetermine an estimate of insulin administered using the insulin deliverydevice. The user interface can display one or more recommended insulindosages using, at least in part, blood glucose data and/or previousestimates of insulin administered, data about prior insulin dosages(e.g., IOB characteristics associated with each of the user-selectableicons or buttons based on at least one of the user-specific dosageparameters. The processor may be adapted to update the mealcharacteristics associated with each of the user-selectable icons orbuttons based upon the blood glucose data.

In accordance with one or more devices, systems, or methods of thepresent disclosure, the systems or methods may include a glucose monitorthat may provide blood glucose data via one or more communication (e.g.,wireless communication) techniques. In some embodiments, a glucosemonitor of systems or methods provided herein can use multiple wirelesscommunication techniques to transmit blood glucose data. For example, aglucose monitor can include a flash near field communication circuit anda wireless radio. In some embodiments, systems and methods providedherein can have one or more insulin pens or pen accessories receiveblood glucose data from a glucose monitor via a first communicationtechnique (e.g., NFC) and have another device (e.g., a mobile device)receive data from the glucose monitor and/or the insulin pens via asecond communication technique (e.g., BLE or UHF). In some embodiments,smart pen or pen accessories in methods and systems provided herein maycommunicate with a continuous and/or glucose monitor of methods andsystems provided herein only within a first range and the mobile devicemay be adapted to passively receive data whenever within a second rangethat is larger than the first range. In some embodiments, smart pens orpen accessories provided herein may be configured so that the smart penor pen accessories only receive data when the user elects to take actionto receive data (e.g., push a “wake up” button and/or bring the pen orpen accessory within a close proximity to the glucose monitor), butanother device (e.g., an associated mobile device) may be adapted topassively receive data regardless of user action if within a rangedetermined by the communication method or link.

In accordance with one or more devices, systems, or methods of thepresent disclosure, a user interface on the smart insulin deliverydevice or accessory therefore can include one or more user-selectablebuttons or icons. In some embodiments, a user-selectable button or iconmay be used to wake up the smart pen or pen accessory to receive bloodglucose data from a blood glucose monitoring/sensor system (e.g., thatincludes a CGM, BGM, flash glucose monitor, etc.). In some embodiments,a user-selectable button or icon may be used to wake up a display on thesmart pen or pen accessory to display a recommended insulin dosageamount for the insulin in the smart pen or in an insulin pen secured tothe pen accessory. In some embodiments, a user-selectable button or iconmay be used to toggle the display between different displays. In someembodiments, a single user-selectable button or icon may be used to wakeup the smart pen or pen accessory to receive blood glucose data and towake up the display, which can then display a recommended insulin dosageupon the smart pen or pen accessory that receives the blood glucosedata. In accordance with one or more devices, systems, or methods of thepresent disclosure, the processor may determine a dosage recommendationof rapid-acting insulin based on factors selected from the number ofcarbohydrates divided by the PWD's carbohydrate-to-insulin ratio, adifference between the current blood glucose level and a target bloodglucose level divided by the PWD's insulin sensitivity factor, a readingfrom a blood glucose meter (BGM), data from a continuous glucose monitor(CGM), blood glucose trend data, Insulin-on-Board (JOB) data,Carbohydrates on Board (COB) data, whether the PWD is exercising orplans to exercise, whether the PWD is sick, whether the PWD is pregnant,whether the PWD is experiencing menses, and whether the PWD has consumedcertain medications.

In some embodiments, a reusable smart pent that may include a dosingdetector, a reusable chamber one or more types of insulin cartridges,and a manual delivery mechanism. The detector may be configured todetect first insulin delivery events associated with a manual deliverymechanism.

System Architecture for Therapy Management System

FIG. 1A illustrates an insulin therapy management system 10 (which mayalso be referred to as a diabetes management system), that includes ananalyte sensor system 101 (in this example, a glucose sensor system101), a first accessory 102, a second accessory 103, and a mobileapplication 104. The insulin therapy management system 10 may includeone or more web services 105 that communicate with the mobileapplication 104 by way of a network 108. The first accessory 102 andsecond accessory 103 are two of many accessories that may join and leavethe insulin therapy management system 10, and serve to assist users withmanual insulin delivery.

While aspects of the embodiments of the disclosure are described interms of accessories and caps, one of ordinary skill in the art wouldunderstand that many of the features could be performed in anelectronics package (i.e., a smart electronics) that is integratablewith an insulin delivery device, attachable to an insulin deliverydevice, attachable to an insulin container, and more, all of which arespecifically contemplated by the inventors of this disclosure.

The first accessory 102 and second accessory 103 may be configured tocapture information related to the delivery of insulin by manualdelivery device 106 and manual delivery device 107, and, in variousembodiments, may include internal sensors for dose capture; userinterfaces for displaying information and receiving user input; andother interfaces for wireless or wired communication with one or more ofthe manual delivery device 106, manual delivery device 107, mobileapplication 104, the analyte sensor system 101, and mobile application104.

The mobile application 104 may execute on any suitable mobile computingdevice that can store and execute a mobile application that is adaptedto display and input therapy relevant information wirelessly receivedfrom the other components of the system as well as from a graphical userinterface that enables user to interact with the application. In oneembodiment, the mobile device can also store and execute a trustedmobile application within a trusted execution environment (hardwareand/or software) that is not, generally speaking, accessible to users ordevices communicating with the mobile device 140 but that is accessibleto other applications executing on the mobile device 140. Variousfunctions and calculations that relate to the therapy management system,including the alerts and recommendations that are presented to users maybe, in part or in whole, performed by the trusted mobile application.Moreover, some or all communication with insulin pens, pen caps, glucosesensors, and other accessories may be restricted to the trusted mobileapplication.

Generally, the embodiments of the disclosure may use any suitablewireless communication protocol for communication among accessories,manual delivery devices, glucose sensors, and mobile devices. Examplesof suitable wireless communication protocols includenear-field-communication (ISO/IEC 14443 and 18092 compliant technology),wireless modems and routers (IEEE 802.11 compliant technology), andBluetooth®/Bluetooth Low Energy (BLE) (IEEE 802.15 complianttechnology).

The glucose sensor system 101 may be any suitable glucose sensor system101, such as a blood glucose meter (BGM) adapted to determine bloodglucose values using blood glucose test strips, and flash glucosemonitor, or a continuous glucose monitor (CGM). In some cases, a glucosesensor system 101 can act as both a flash glucose monitor and acontinuous glucose monitor by permitting both intermittent and on-demandtransmissions of blood glucose data. In some embodiments, the glucosesensor system 101 can wirelessly transmit data when interrogated by areader device (e.g., using NFC communication). In some embodiments, theglucose sensor can wirelessly transmit data at predetermined intervals(e.g., using radio frequencies) using any suitable communicationstandard (e.g., Bluetooth Low Energy (BLE)). In some cases, systems andmethods provided herein can include multiple glucose sensor systems(e.g., a continuous or flash glucose monitor and a blood glucose meter).

In some embodiments, an accessory may be associated with a particulartype of insulin, for example, the first accessory 102 is associated withlong-acting insulin delivery and the second accessory 103 is associatedwith rapid-acting insulin delivery.

In some embodiments, the glucose sensor system 101 can transmit glucosedata using multiple communication techniques. In some embodiments, themobile application 104 and/or one or more of the manual delivery device106, 107 or accessories 102, 103 may include an NFC reader adapted toobtain blood glucose data from the glucose sensor system 101 whenbrought within an interrogation distance of the glucose sensor system101. In some embodiments, the mobile application 104 and/or one or moreof the manual delivery device 106, 107 or accessories 102, 103 maywirelessly receive blood glucose data from the glucose sensor system 101that is broadcast at predetermined periods of time (e.g., every 30seconds, every minute, every 2 minutes, every 3 minutes, every 5minutes, every 10 minutes, every 15 minutes, etc.).

In a polled (or interrogated) mode of operation, the glucose sensorsystem 101 may wirelessly send blood glucose data to one or more of theaccessories 102, 103 and the mobile application 104, that corresponds toa historical period. For example, when the first accessory 102interrogates the glucose sensor system 101 it may receive stored glucosedata from the previous 1 hour, 2 hours, 3, hours, 4 hours, 5 hours, 6hours, 7 hours, 8 hours, etc. In some cases, broadcast blood glucosedata may only include a current or more recent blood glucose value. Forexample, in some cases blood glucose data received on the mobileapplication 104 received directly from the glucose sensor system 101 mayinclude only the most current readings (e.g., from the last 10 minutes),which may be used by the mobile application 104 to issue alarms oralerts based on the most current blood glucose data.

Accessories 102, 103 can include one or more processors and memory forcontrolling wireless communications, controlling interfaces for wirelesscommunication, controlling a user interface, and/or determining therapyrecommendations.

In some embodiments, an application running at the accessories 102, 103may execute one or more algorithms to determine estimated glucose values(EGVs) from raw glucose sensor data. In some embodiments, a glucosesensor system 101 can transmit EGVs to an accessory. In someembodiments, accessories and/or smart electronics provided herein caninclude memory that stores user-specific dosage parameters (e.g., arecommended daily dose of long-acting insulin or total daily basal dose(TDBD), insulin sensitivity factor (ISF), carbohydrate-to-insulin ratio(CR), correction amounts based on blood glucose level ranges, totaldaily insulin dose (TDD), target glucose value, recommended rapid-actingdoses for different meal sizes or categories, etc.). In someembodiments, user-specific dosage parameters may be time or daydependent, such as CR and ISF values that depend on the hour of the day.In some embodiments, accessories 102, 103 provided herein can havememory that stores recommended doses of rapid-acting insulin fordifferent meals or for different meal categories. In some embodiments,user-specific dosage parameters and/or different recommended doses fordifferent meals may be updated via mobile application 104 in wirelesscommunication with an accessory. For example, an algorithm in the mobilecomputing device or in the cloud can update these parameters orrecommended doses. In some embodiments, parameters or recommended dosesmay be updated by a healthcare professional or manually by the PWD or acaregiver. In some embodiments, the accessory can include an algorithmin memory to be executed by a processor to automatically update theuser-specific dosage parameters or recommended doses.

Accessories 102, 103 provided herein can, in some embodiments, displayor otherwise provide notice to a user of a current blood glucose leveland/or blood glucose trend data (e.g., a rate of change) based onglucose data received from the glucose sensor system 101. Accessories102, 103 (or other smart electronics) provided herein may providerecommended doses of insulin based on one or more of blood glucose data,user-specific dosage parameters, recommended dosage amounts set by auser or healthcare professional, time-of-day, meal data orcategorizations, or any other suitable input.

While system 10 is described with two accessories 102, 103, it is notlimited and may include more or fewer accessories. For example, firstaccessory 102 may include a pairing or discoverable mode where itbroadcasts information that is discoverable by mobile application 104.The broadcast may be according to a BLUETOOTH beacon or other suitablecommunication protocol. Responsive to pairing confirmation such asholding the first accessory 102 and mobile device hosting the mobileapplication 104 close together or depressing a button for sufficienttime either at the first accessory 102 or mobile application 104, themobile application 104 may create a profile for a manual delivery devicethat is associated with the first accessory 102. In one embodiment, thefirst accessory 102 may be specifically calibrated for a specific typeof manual delivery device and may provide a delivery device typeidentifier to the mobile application 104. In another embodiment, whenthe first accessory 102 and mobile application 104 are paired, setupinformation may be provided at the mobile application 104 or at theinterface of the accessory.

In one embodiment, pairing may also involve sharing encryption keys thatthe devices may use to decrypt/authenticate messages from devices withinthe system 10.

Each accessory that is paired with the system 10 may have a profilecreated by the mobile application 104. In one embodiment, the mobileapplication 104 may query web services 105 for whether a profile for adevice already exists for a user, and, if it does, request that it besent. This enables the mobile application 104 to avoid reduplicatingsetup as well as may make available to the recommendation algorithmsrunning at the mobile application 104 more historical data orphysiological attributes of the user (e.g., insulin sensitivity) thathave been refined by actual glucose measurements and blood glucoseresponse analysis.

Upon creating the profile, the mobile application 104 may save insulintherapy related settings with the profile. The insulin therapy relatedsettings may include user-specific dosage parameters for a user,delivery characteristics of the device, specific techniques that may beused to determine recommendations.

In one embodiment, each manual delivery device profile may include, orbe part of a user profile that includes, pre-configured correction dosesfor particular blood glucose ranges. In one embodiment, thepre-configured doses may be entered at the mobile application 104. Inanother embodiment the pre-configured doses may be entered at one of theweb services 105 (e.g., by a healthcare provider or parent), anddownloaded to the mobile application 104.

As will be described in more detail below, in one embodiment, a user mayselect from among the available doses and the system will monitor fordosing actions at an associated manual delivery device. As describedmore fully herein, dosing actions may be specifically detected (e.g., bydetecting medication exiting a needle of a delivery device) or inferred(e.g., using capping information). In some cases, the correction dosesmay not be available for a limited period of time after insulin dose ordetected possible dose. For example, methods, systems, and devicesprovided herein may be able to detect a dose or possible dose, but notbe able to determine a dose amount, thus such systems, methods, anddevices may not be able to determine an amount of active insulin (e.g.,IOB) remaining in the user, thus such systems may prevent thecalculation or suggestion of a correction does for a certain period oftime (e.g., at least 2 hours, at least 3 hours, at least 4 hours, or atleast 5 hours) after a prior detected dose or detected possible dose ofrapid-acting insulin.

Since, meal dose recommendations may be calculated for a manual deliverydevice that has rapid-acting insulin, a profile may also include orrefer to algorithms for calculating meal doses for offsetting theeffects on blood glucose levels of small, medium, or large meals. In oneembodiment, the algorithms may be personalized to a user, initially,with physiological information about the user, and over time,personalized using actual glucose sensor data and dosing eventinformation.

The mobile application 104 is configured to record historical therapyrelated information, for example, a history of blood glucose levels,dosing amounts, dosed medication, and dosing timing information.

The system 10 is also configured such that an accessory may be removed.For example, at a setup screen of the mobile application 104 a user mayselect a manual delivery device 107 to be removed/unpaired from thesystem 10. Responsive to a selection, the manual delivery device 107 mayinitiate a confirmation prompt to the user. In one embodiment, aconfirmation process involving a specific user action (e.g., holdingdown a button at a mobile device and a button at the accessory4) may beused to confirm the removal. Responsive to the confirmation the deviceprofile may be stored and the second accessory 103 may change to anunaffiliated state and power down.

The system 10 is also configured to add and remove glucose sensor system101, and other glucose monitoring devices configured to send bloodglucose data. For example, and as described below, swiping or wavingsecond accessory 103 within proximity of glucose sensor system 101 mayactivate a communication link between second accessory 103 and theglucose sensor system 101. In one embodiment, the communication link maybe initiated according to a near-field-communication (NFC) protocolwhere an antenna and reader IC at the accessory interrogates a tag(typically a chip) at the glucose sensor system 101.Affiliation/activation data may be shared among the system so that otherdevices (accessories, mobile devices, etc.) may access the blood glucosedata at the glucose sensor system 101.

Background Activity and Sync

The following activities may be carried out in the background when thenecessary devices are available and online. These activities aredescribed in the following workflow and may vary based on system status.For the following description, the first accessory 102 is associatedwith long acting insulin delivery and the second accessory 103 isassociated with rapid-acting insulin delivery.

Program Execution on First Accessory Associated with Long-Acting InsulinDelivery

In one embodiment, the first accessory 102, or a device in communicationwith the first accessory 102, may execute software to calculate a user'srequired long-acting insulin dose. In one embodiment glucose measurementvalues are sent to a long acting insulin dose recommendation servicehosted in the cloud. In various embodiments, the glucose values may besent to the cloud services (e.g., via a wireless or cellular connection)at regular intervals such that updates to the therapy parameters may bemade, as described in the workflow above. In one embodiment the pen cap112 may include wireless or cellular equipment and may send the glucosevalues to the cloud service via wireless or cellular connection. Inanother embodiment, the first accessory 102 may piggyback on thewireless or cellular connection of a mobile device at which the mobileapplication 104 executes. The first accessory 102 periodically backs updata to the cloud via the mobile application 104 (e.g., via a localconnection, such as a BLUETOOTH® or BLE connection).

The first accessory 102 may receive updated therapy parameters back fromthe cloud or web services 105 when they are approved and available. Dataflow examples are described, below.

Program Execution on a Second Accessory Associated with Rapid-ActingInsulin Delivery

In one embodiment, the second accessory 103 associated with rapid actinginsulin delivery, or a device in communication with the second accessory103, executes the software containing the algorithm to calculate theuser's required rapid-acting insulin dose. Glucose values and mealchoices may also be sent to a rapid-acting insulin dose recommendationservice as well as (e.g., via a wireless or cellular connection) atregular intervals such that calculations may be made as described in theworkflow above. In one embodiment the second accessory 103 may includewireless or cellular equipment and may send the glucose values to thecloud service via wireless or cellular connection. In anotherembodiment, second accessory 103 may piggyback on the wireless orcellular connection of a mobile device having the mobile application 104installed and executing thereon. The second accessory 103 periodicallybacks up data to the cloud via the mobile application 104 (e.g., via alocal connection, such as a BLUETOOTH® or BLE connection).

The second accessory 103 receives updated therapy parameters back fromthe cloud services when they are approved and available. This flow ofdata is discussed in a later section.

Program Execution on Mobile App

The mobile application 104 may run in the background to sync with BLEdevices (e.g., first accessory 102 and second accessory 103, glucosesensor system 101) and the cloud to act as a conduit of information.Information is synced regularly per the descriptions above.Additionally, system status configuration, dose history, and glucosetrends and forecasting may be viewed as they are calculated in the cloudand pushed to the mobile application 104.

Updating Therapy Parameters

As shown in FIG. 1A, the cloud service may execute an algorithm toupdate and individualize the user's therapy parameters over time (ISF,CR, TDBD, glucose target, correction chart, meal category doses) basedon information provided from the local system (e.g., to the cloud).These values may be updated when data is pushed from the accessories102, 103 via the PWD's mobile application 104 to the cloud. In oneembodiment, when a new value is ready to be pushed to the user's mobileapplication 104, it may be first pushed to a healthcare-provider's(HCP's) Web Portal for approval (e.g., via a wireless or cellularconnection).

In some cases, a portal may alert an HCP that a new set of parameters isready for review. The clinician may then review the values and eitherapprove or reject them. If rejected, the cloud service is notified andno other action occurs.

If accepted, the cloud or web service 105 is notified and the values(e.g., the updated parameters) are pushed to the user's mobileapplication 104 for acceptance (e.g., via one of the local devices ofthe system, such as the accessories 102, 103, and/or the mobileapplication running on a mobile device). For example, the values may betransmitted to the mobile application, which then communicates thevalues locally to one or both of the accessories 102, 103.

In some cases, an algorithm can determine if an update is suggested andsend a notice to the user that suggests that the user update the user'stherapy parameters (perhaps in consultation with the user's doctor).

FIG. 14 shows an example process for updating therapy information,according to an embodiment of the disclosure. In operation 502, a useraccesses therapy settings using the mobile application 104. The therapysettings may be stored at the mobile application 104, the accessories102, 103, or both. In operation 504, new therapy settings are providedvia a user interface provided by the mobile application 104 andconfigured to receive new settings. In operation 506, the mobileapplication 104 may present a notification at the user interface thatsettings need to be synced to the accessories 102, 103. In operations508 and 510, the mobile application 104 may wirelessly communicate oneor more of the new settings to the accessories 102, 103. In oneembodiment, long acting relevant therapy settings are sent to theaccessory associated with long acting insulin delivery and rapid-actingrelevant therapy settings are sent to the accessory associated withrapid-acting insulin delivery.

Pen Cap and Insulin Pen System Architecture

During use, insulin therapy management system 10 may assist a PWD (ortheir caregiver) responsible for determining when to inject insulin andhow much insulin to inject. System 10 may be configured to providerecommendations to assist the PWD (or caregiver) in determining anappropriate insulin dose based on current data from the glucose sensor,based on stored therapy parameters, and/or based on data about insulininjections. In some embodiments, the accessories 102, 103 are configuredto collect and provide data about insulin injection events.

In one embodiment the manual delivery devices 106 and 107 shown in FIGS.1B and 1C, may be insulin pens, including, commercially-availablemechanical insulin pens that include any suitable insulin, for example,long-acting insulins and rapid-acting insulins (sometimes calledquick-acting insulins or ultra-fast rapid-acting insulins). Suitablerapid-acting insulins include HUMALOG®, NOVOLOG®, APIDRA®, and FIASP®.Suitable long-acting insulins include LANTUS®, LEVEMIR®, TOUJEO®, andTRESIBA®.

By way of example, manual delivery device 107 may be a long-actinginsulin injection pen 110, and manual delivery device 106 may be arapid-acting insulin injection pen 120 as shown in FIGS. 1B and 1C. InFIG. 1B, shown is an insulin therapy management system 11, insulin pen110, insulin pen 120, CGM 130, and mobile device 140 which has a therapymanagement mobile application executing thereon. The first accessory 102may be a pen cap 112 and the second accessory 103 may be a pen cap 122.In FIG. 1C, shown is an insulin therapy management system 12, insulinpen 110 having pen cap 112, insulin pen 120 having pen cap 122, CGM 130,blood glucose meter (“BGM”) 150, and mobile device 140 which has atherapy management mobile application executing thereon. As shown,system 12 has the components of system 11 but also has a BGM 150 and adifferent mobile application display of blood glucose values.

The insulin pens 110, 120 may include dials (not shown) that may be usedto configure the pens to inject a dose of insulin that corresponds tothe dial turn. In some embodiments, each insulin injection pen may be areusable insulin pen that includes a display or audio and/or inputdevices such as those disclosed for the pen caps disclosed herein. Oneexample of a reusable insulin pen is an insulin pen that includes achamber for unloading depleted insulin cartridges and loading newinsulin cartridges. The insulin pens 110, 120 may include interfaces forwireless and/or wired communication with one or more of the pen caps,glucose sensor, mobile devices, and other accessories.

Pen capping information (i.e., information about when the pen cap issecured to and/or released from an insulin pen—also referred to hereinas “capping” and “uncapping” respectively) can include information abouta current capping period (e.g., the time since the last capping),information about a duration of one or more uncapping, and the timing(e.g., time-of-day or time elapsed since) of each uncapping and eachcapping. In some embodiments, pen capping information may be displayedat an interface of a pen cap to a user. In some embodiments, pen cappinginformation may be announced by a speaker in the pen cap. For example,in some embodiments, a pen cap may provide a timer clock that counts up(or a timer that counts down) from the last time the pen cap was securedto an injection pen. In some embodiments, a pen cap can wirelesslycommunicate pen capping information to mobile device 140 (e.g., asmartphone, tablet, etc. running a mobile application).

Pen capping information may be used to adjust the user experience. Insome embodiments, the pen cap adjusts the presentation of therapyrelevant information and/or recommendations provided to the userresponsive to the pen capping information. For example, in someembodiments, a pen cap may provide bolus recommendations to correct forelevated glucose levels based on data from a CGM 130, but may limit thepresentation of such correction bolus recommendations to time periodswhen the current pen capping duration is greater than a threshold periodof time (e.g., at least 3 hours, at least 4 hours, or at least 5 hours).In some embodiments, the pen caps 112 and 122 may provide notifications,alerts, and/or alarms to the user based on the pen capping information(e.g., based on the amount of time that a pen has been capped and/oruncapped). For example, if the pen caps 112 and 122 are removed from aninjection pen within a threshold period of time (e.g., within 30 minutesor 1 hour for a rapid-acting insulin, within 6-12 hours for along-acting insulin) from a previous capping, the pen cap may provide avisual, audible, and/or tactile notification to indicate that the usermay have recently used the pen to administer insulin. In someembodiments, the pen caps 112 and 122 may be in wireless communicationwith a mobile device 140 and one or more notifications, alerts, and/oralarms based on pen capping information may be announced or displayed onthe mobile computing device.

A capping sensor for detecting possible capping events, uncappingevents, and recapping events may be an analog or digital electronicsensor integrated with a pen cap, or, more generally, with an accessory,that responds to being attached or removed from an insulin pen. In oneembodiment, it may incorporate a piezoelectric material that generates asmall current when pressure (e.g., from being firmly affixed to aninsulin pen) is exerted on it. In another embodiment, it may respond torelative motion between itself and a small magnetic element affixed tothe medical delivery device. In yet another embodiment, it may respondto an open and closed circuit (e.g., open loop when cap off, closed whencap is on). Any suitable sensor for detecting capping and uncapping maybe used.

Capping/Uncapping Events and Dosing Events

Pen capping information may be stored, displayed, and analyzed incombination with glucose data to determine user behaviors, such aswhether the person is appropriately dosing insulin for meals and/or tocorrect elevated blood glucose levels. In some embodiments, pen cappinginformation may be presented on a graphical representation of bloodglucose data for the user and presented to a user and/or to a healthcareprofessional. In some embodiments, blood glucose data from a period oftime after each capping event may be evaluated to determine whether theuser appropriately dosed insulin for that capping event, under-dosed, orover-dosed.

In some embodiments, a pen uncapping event, pen capping event, or penrecapping event may be disregarded where other information indicatesthat a dose was not provided. For example, where no change in the dosageselection of the insulin pen (e.g., a dial) was detected, the event maybe disregarded.

In one embodiment, pen caps 112, 122 may be configured to track pencapping events that may be used to infer dosing actions. In variousembodiments, the systems 11 and/or 12 may be configured to infer that acapping event corresponds to a dosing action and record it (e.g., as adosing event), including one or more of the time, type of insulin, andamount of insulin delivered. In one embodiment, the amount of insulindelivered may be captured at the insulin pens 110, 120 and provided tothe pen caps 112 and 122. In some embodiments, pen caps 112, 122 candetermine and track remaining insulin in the insulin pens 110, 120 basedon the amount of each dose. In another embodiment, the pen caps 112, 122may track the amount of insulin that remains in an insulin cartridge anddetermine an amount of insulin associated with a dosing action based ona change of the amount of insulin in an insulin cartridge. In additionalembodiments, smart pens or pen accessories can detect the dosages set oradministered using other suitable techniques.

In some embodiments, the pen caps 112, 122 may include one or more ofsmart sensors to detect a substance on a user's fingers, sensors, suchas a temperature sensor to determine (e.g., along with blood glucosedata) if the insulin needs to be replaced or has gone bad, a touchscreen, and a capacitive touch button. For example, one or more of themobile application or the pen caps 112, 122 may include a temperaturemonitor that monitors one of more of average temperatures, hightemperatures, or low temperatures experiences by the pens caps 112, 122.Such temperature ranges and/or minimum and maximums may be attributed tothe therapy (e.g., insulin) attached to the pen caps 112, 122. Uponexposure to a minimum and/or maximum temperature (e.g., or a selectedtime period within a selected temperature range), the pen caps 112, 122may provide an alert and/or alarm to the user that the insulin has beenexposed to an out of range temperature (e.g., a level beyondrecommendations for user and/or storage of the insulin).

In some embodiments, such a temperature sensor may be used in unisonwith the blood glucose sensor to indicate, where the insulin has beenexposed to a select temperature level, that the insulin is not having anexpected effect on the subject's blood glucose level. For example, analarm and/or alert may be provided where the insulin has been exposed toan out of range temperature and where data from the blood glucosemonitor data is indicating that the insulin is not having an expectedeffect on the subject's blood glucose levels (e.g., less than or morethan an expected change). In some cases, methods, systems, and devicesprovided herein can condition notifications regarding temperatureexposure based on additional data that indicates that the effectivenessof the insulin has been compromised or may have been compromised inorder to mitigate against the user experiencing notification fatigue. Insome embodiments, the mobile application or the pen caps 112, 122 maytrigger a reminder for the user to make a post-injection reading todetermine the effectiveness of the insulin that was recently provided tothe subject.

In some embodiments, the mobile application or the pen caps 112, 122 maycommunicate with a wearable device on the PWD (e.g., a smartwatch) todetermine an action being undertaken by the subject (e.g., if thesubject is eating). For example, a wearable application may execute onthe wearable device that enables a user to interface with one or more ofthe pen caps 112, 122, the insulin pens 110, 120, the mobile device 140,and other accessories. In some embodiments, the wearable application mayinterface with a mobile application executing on the mobile device 140,such as mobile application 104. The mobile application may perform theprocessing for various features described herein, and the wearableapplication may serve the alerts and recommendations to a user as wellas serve information to the mobile application received from the user atthe wearable device, such as indications of a meal, exercise, or dosingaction.

Swiping/Gathering Glucose Information

FIG. 2 illustrates a PWD utilizing one or more portions of the insulintherapy management system 11 of FIG. 1B. As shown in FIG. 2, a PWD 20can have, e.g., a glucose sensor system 101 applied to their arm so thatit can detect the PWD's blood glucose levels, and a user may use pen cap122, secured to rapid-acting insulin pen 120, to interrogate glucosesensor system 101. Before and after the user swipes the pen cap 122 inFIG. 2, pen cap 122 can display therapy relevant information.

FIG. 3 illustrates a display on a pen cap. As shown in FIG. 3, forexample, a display 124 on pen cap 122 can depict a time 125 of the mostrecent dose (e.g., the time and/or date of the last dose), or “lastdose,” which can assist a user in remembering if they bolus for a recentmeal and help a user avoid the unintentional stacking of boluses. Insome embodiments, such as cases with pen caps capable of detecting anamount of a dose, the display can additionally display the number ofunits of the last dose. In some embodiments, the timing of the last dosecould be a clock that ticks up to indicate how long ago the last dosewas administered. In some embodiments, the display might depict a mostrecently obtained blood glucose level and the time it was obtained. Insome embodiments, the display might be a bistable display, such as anelectronic paper display. Electronic paper displays are displays thatmimic the appearance of ordinary ink on paper. In some embodiments, thedisplay can include identifying information (e.g., a label identifyingthe user, such as “Sarah's pen”) and/or information about the type ofinsulin pen that the pen cap is attached to (e.g., the brand of insulin,whether the insulin is rapid-acting or long-acting, etc.). As shown, pencap 122 can include a button 123, which may be used to wake up (change amode) the pen cap, toggle between screens, and/or provide otherfunctionality.

FIG. 4 depicts pen cap 122 showing blood glucose data 129, which caninclude a current blood glucose level and a trend arrow. The bloodglucose level may be received from glucose sensor system 101 afterscanning the pen cap 122 as shown in FIG. 2. In some embodiments,placing the pen cap 122 in proximity to the glucose sensor system 101(e.g., scanning over the glucose monitor 130) may act to wake the pencap 122 from an idle mode. In some cases, pushing button 123 can wake upthe pen cap 122 to allow for a scanning of the glucose sensor system101. In some cases, removing pen cap 122 from the pen 120 can wake upthe pen cap 122 to allow for a scanning of the glucose sensor system101.

Delivery Recommendations for Rapid Acting

In one embodiment, system 11 and/or system 12 may be configured toprovide a correction dose recommendation and present the recommendationat a user interface. Turning to FIG. 4, the display of the pen cap 122includes a recommended correction dose 127 d and a correspondingcorrection dose icon 126 d. If the user's glucose level is in anacceptable range, the pen cap 112 may, responsive to a recommendationsystem, display information indicating no correction dose is needed. Insome embodiments, further input may be entered by or required from theuser, such as, for example, an indication of a meal (e.g., where the pencap 112 may then display a number of meal options, as discussed below)for the user to select. In some cases, button 123 may be progressivelypushed to increase the size of the meal, to progressively display largermeal sizes, and/or to highlight different meal sizes. The dosagerelating to the meal and any correction dose, if necessary, may beprovided to the user along with an indication of the size of the meal.The indication of the size of the meal may be based on a size of anicon, a displayed number of carbohydrates, and/or a label (e.g., Smallor S, Medium or M, Large or L). In other embodiments, the mealindicators or icons may be based on other characteristics of the meals,such as, for example, preferred meal selections made by the user, mealshaving a selected nutritional characteristics (e.g., carbohydrates),certain meals based on time of day (e.g., breakfast, lunch, dinner,snack), etc.

A recommended correction dose may only be valid for a set period oftime, for example, because blood glucose levels change due to factorssuch as basal metabolism, meals, and exercise. In one embodiment, thepen cap 122 may be configured to display a recommended correction dosefor a set period of time (e.g., a period of time from the last scanningevent as shown in FIG. 2). The set period of time may be user defined orit may be determined based on a confidence level that corresponds to theage of the recommendation and physiological factors of the user. Thus, arecommended correction dose may have an associated confidence level and“rate of decay” for that confidence level. After the timer expires(e.g., within the last 5, 10, 15, 20, 30 minutes, or more) the pen cap122 may stop displaying a recommended correction dose. In some cases,the pen cap 122 may stop displaying a recommended correction dose when areceived glucose value expires (e.g., it is more than 10, 15, 20, or 30minutes old). In various embodiments, glucose data transmitted from aglucose sensor system 101 to a pen cap 122 in a single transmission caninclude data that may be used by the pen cap to determine at least twoestimated glucose values (EGVs) for a time period extending for at least30 minutes. In some embodiments, a single transmission can include atleast 1 hour of glucose data, at least 2 hours of glucose data, at least4 hours of glucose data, at least 6 hours of glucose data, or at least 8hours of glucose data. For example, a CGM and/or flash glucose monitor,such as glucose monitor 130, can transmit multiple hours of glucose datain a single transmission event.

In one embodiment, responsive to expiration of the timer, the display124 on the pen cap 122 may instruct the user that a new blood glucosereading is needed before an updated recommendation may be made based onthe blood glucose data. In some cases, a pen cap that does not havecurrent blood glucose data may provide recommendations based on the mealsizes alone, but may optionally additionally include an indication thatthe recommendation does not include a correction component.

In one embodiment, a correction dose may only be displayed if a currentblood glucose value is available (for example, a valid blood glucosevalue from the previous 10 minutes, from the previous 15 minutes, orfrom the previous 30 minutes). If no valid blood glucose value isavailable, a message may be displayed to a user that a current bloodglucose value is needed.

FIG. 5 depicts pen cap 122 with meal-related dosing recommendations(referred to herein as “meal recommendations”) 127 a-127 c, which may bedisplayed for differently sized meals that are identified by meal icons126 a-126 c. For example, in use, a user might press button 123 toobtain meal recommendations after seeing the screen of FIG. 4. In someembodiments, the meal recommendations may be based on meal doses thatare set by a healthcare professional, the PWD, and/or a caregiver usingthe mobile application during set up or as updated by the health careprofessional, the PWD, and/or caregiver. In some embodiments, the mealrecommendations may be based on user-specific dosage parameters that areautomatically updated by the system, using any suitable algorithm toupdate dosage parameters. In some embodiments, when the user hasrecently (e.g., within the last 5, 10, 15, 20, 30 minutes, or more)obtained a blood glucose reading, meal recommendations 127 a-127 c caninclude both a meal dosage and a correction dosage. In some embodiments,the meal recommendations 127 a-127 c may include only a meal dosage andthe pen cap 122 may not require that the user scans a glucose sensor inorder to receive the meal recommendations 127 a-127 c.

In some embodiments, pen caps 112 may refuse to provide a correctiondose for a predetermined period of time after a prior dose and/or for aperiod of time after a prior dose based on a determination of an amountof active insulin (e.g., JOB) in the PWD. In some cases, correctiondoses may be adjusted based on an estimation of active insulin (e.g., anIOB estimate). In some cases an IOB may not be known, but an estimatedpercentage of the prior dose remaining active maybe be determined anddisplayed to a user. In some cases, a correction dose calculation may bereduced based on an estimated percentage of active insulin remainingbeing within a predetermined range (e.g., active insulin remaining beingdetermined to be between 5% and 25% results in a 25-75% reduction incorrection doses recommended). For example, the pen caps 112 maycontinue to increase a recommended correction dose over time betweenhours 2 and 4 after a prior dose based on estimated active insulinpercentage in the subject.

Alarms/Alerts Thresholds on Dosing Actions

In some embodiments, if pen cap 122 has identified other recent doses(e.g., by detecting a capping action of the pen cap within the last 3hours, the last 4 hours, or last 5 hours) without knowing the amount ofthe dose, the pen cap might refuse (e.g., initially refuse, with anoptional override) to add a correction component in order to prevent theunintentional stacking of correction boluses. In some embodiments, mealicons 126 a-126 c can indicate whether the recommendation includes acorrection component or not. In some embodiments, additional icons ordisplays can indicate if there is a recommended correction dose includedand/or the size of the recommended correction dose. In some embodiments,by pushing button 123, the user can obtain a screen that displays thecurrent blood glucose value, trend information (e.g., a trend arrow),and a recommended correction dose. In some embodiments, if there hasbeen a recent dosage of insulin (e.g., within the last 1, 2, 3, or 4hours) a warning screen might appear next to or over the recommendationto indicate that there has been a recent dose in order to preventunintentional stacking of insulin. In some embodiments, a notice icon128 can appear on pen cap 122 in order to indicate to the user that amore detailed suggestion, tip, alert, or alarm is available for the userin the mobile application on the mobile device 140.

Recommendation Specific to Long Acting Insulin Delivery

FIG. 6 depicts pen cap 112, which may be used on a long-acting insulininjection pen 110. In some embodiments, pen cap 112 and pen cap 122 mayshare one or more (e.g., a majority of, all) operational features. Asshown in FIGS. 3 through 6, pen caps 112 and 122 can have distinctvisual appearances (e.g., different colors, markings, patterns, etc.) orphysical structures (shapes, textures, etc.) to assist the user todistinguishing between long-acting insulin and rapid-acting insulin, asthe unintentional delivery of the wrong type of insulin can causehypoglycemic or hyperglycemic events. Pen cap 112 can include a button113 and a display 114 (e.g., an electronic paper display). When button113 is pressed by the user (e.g., to wake the pen cap 112), the display114 can remind the user about the amount of long-acting insulin 117(with an appropriate icon 116) that the PWD should inject based onstored therapy parameters (e.g., even without having received a bloodglucose reading from an associate blood glucose sensor).

In some embodiments, if the user has recently uncapped pen cap 112 frompen 110, the display can depict information about when the pen cap 112was uncapped or other warnings to prevent the unintentional doubledelivery of long-acting insulin. In some embodiments, pen cap 112 mayprovide a notice sound to indicate to a user that it is time to deliverthe long-acting insulin based on stored therapy parameters. In somecases, methods, devices, and systems may provide an alarm, alert, ornotification to a user (e.g., via a pen cap or via a mobile app) if theuser has not taken a dose within a certain threshold period of time of aschedule dose time (i.e., a “missed dose”). In some embodiments, asuitable therapy titration algorithm may suggest that a user change thestored therapy parameters and/or automatically update the stored therapyparameters relevant to the dosing of long-acting insulin.

In some embodiments, long-acting insulin pen cap 112 may infer dosingactions using pen capping information. If a dosing action is notinferred for a certain time or within a certain time range, then pen cap112 may detect a missed dose of long acting insulin. A missed dosealarm, alert, and/or notification to a user may be generated andprovided to a user. A missed dose notification may include informationabout the missed dose, including an expected time and an expected amountof long acting insulin to be delivered.

In some embodiments, a time threshold parameter may be provided thatdefines a period of time since a last inferred dosing action. The timethreshold parameter may be configurable, so a user may set differenttime periods (e.g., values may be entered by a user or selected fromamong a list of recommended time periods in a setup screen). If a timesince a last inferred dosing action exceeds a time threshold parameterthen a missed dose may be inferred and a missed dose alarm, alert,and/or notification may be generated and provided to a user.

In some embodiments, pen cap 112 can interrogate glucose monitor 130 toreceive glucose data and/or receive blood glucose data via the mobiledevice 140 and/or pen cap 122. In some embodiments, display 114 candepict recent blood glucose data, the time of that data, and/or glucosetrend data (e.g., a trend arrow). In some cases, pen cap 122 may beadapted so that it does not display a current blood glucose level inorder to avoid a user confusing rapid-acting pen cap 122 withlong-acting pen cap 112. In some embodiments, display 114 may include arecommended dose of long-acting insulin 117. In some cases, if acorrection dose is needed, pen cap 112 may indicate that the user shouldalso deliver a correction dose of rapid-acting insulin using pen 120.

Therapy Relevant Information

In some embodiments, one or more of the pen caps 112, 122 may track anddisplay the estimated percentage of an administered dose over time. Forexample, the pen caps 112, 122 may track an estimated percentage ofactive insulin (e.g., IOB) remaining in a subject over time after eachdose has been administered. In some cases, an IOB percentage leftindicator may be displayed based on the time of the most recent capping(e.g., immediately after capping an IOB percentage left indicator mayindicate that the IOB remaining is 100%, but then be reduced over timeafter the last capping until it hits zero). In some cases, pen cap 112can include a rapid-acting insulin active percentage calculation, whichmay decay over a 3-6 hour period. In some cases, pen cap 122 can includea long-acting insulin active percentage calculation, which may decayover a 12-36 hour period. In some cases, a pen cap adapted for anintermediate-acting insulin may determine a percentage of activeintermediate insulin, which may decay over a 6-12 hour period. In somecases, pen caps 112 and/or 122 may be adapted to determine an amount ofinsulin remaining in an insulin injection pen and thus determine dosageamounts and display a real-time estimation of active insulin as a numberof units of insulin for each type of insulin.

Example System Architecture

FIG. 7 depicts example communications architecture for a system (e.g.,the system 11 depicted in FIG. 1B) showing possible communication linksbetween components of the system. The various components can interfacewith each other via controlled wireless, NFC, or BLE protocols. Each ofthese components display, transmit, and receive information based on thesystem workflow in-progress at the specified point in time. As shown,glucose monitor 130 can communicate via NFC with rapid-acting pen cap122, communication link 231, and/or with mobile device 140,communication link 232. In some cases, a second BLE communication link232 may be between mobile device 140 and glucose monitor 130, which canpermit real-time alarms or alerts based on current blood glucose beingreceived by the mobile device 140 via BLE communications without theneed for user action. In some embodiments, long-acting pen cap 112 cancommunicate with glucose monitor 130 via NFC communications. In someembodiments, long-acting pen cap 112 does not directly communicate withthe glucose monitor 130 via NFC (or, in some embodiments, a BGM viaBLE), which may prevent user confusion due to the fact that onlyrapid-acting insulin should be used for a correction or meal dose. Insome embodiments, glucose monitor 130 can additionally communicate withthe mobile device via a wireless radio that transmits glucose values arepredefined intervals. Both pen caps 112 and 122 can communicate with themobile device 140 via BLE communications. Glucose data, programmedtherapy parameters (e.g., daily dosage of long-acting insulin, dosagesfor different meal sizes (which can vary by time of day), insulinsensitivity factor, carbohydrate-to-insulin ratio, etc.), pen cappingdata (and, optionally, dosage amount data if detected by the pen caps)may be communicated between the mobile device 140 and each pen cap 112and 122, and system data may be communicated via WiFi or cellularconnection 241 to web service 250 (which may be any remote server). Insome embodiments, each pen cap 112, 122 can include a processor andmemory configured to run algorithms to determine recommended dosages. Insome embodiments, the mobile device 140 can execute therapyrecommendation or therapy parameter update algorithms to recommendchanges to programmed therapy parameters and/or to automatically updateprogrammed therapy parameters. In some embodiments, web services 250 canexecute algorithms to recommend changes to programmed therapy parametersand/or to automatically update programmed therapy parameters. In someembodiments, the timing data from the capping and/or uncapping events(Capping events and uncapping events may, individually, be referred toherein as “capping events.” Another event that generates cappinginformation is an uncapping event followed by a recapping event) of thepen caps 112 and 122 may be included in the algorithms for providingtherapy recommendations.

In some embodiments, initial therapy parameters may be programmed intothe mobile application on mobile device 140 and transmitted to the pencaps 112 and 122 via BLE communication links 211 and 221. In someembodiments, pen cap 122 can use therapy parameters received from themobile app to recommend correction doses and meal doses. In someembodiments, the therapy parameters can include meal doses fordifferently sized meals (e.g., small meal, medium meal, and large meal).In some embodiments, the therapy parameters can include a therapyparameter for correcting glucose values, such as an insulin sensitivityfactor. In some embodiments, the correction may be based on a linearsliding scale correction, such as discussed below. In some embodiments,pen cap 112 can receive a therapy parameter indicating a daily amount oflong-acting insulin. In some embodiments, pen cap 112 can receiverecommended times for dosing long-acting insulin from the mobileapplication of mobile device 140 (e.g., every day at 9 p.m., every dayat 8 a.m., twice a day at 8 a.m. and 8 p.m., etc.).

Delivering a Rapid-Acting Insulin Dose

When the user decides to deliver a rapid-acting insulin dose (forexample, before a meal), the system can initiate the following workflow.Some of the acts are optional and may not be invoked if particulardevices are unavailable or if the user chooses not to use them.

Acquire Glucose Reading

The user may initiate an NFC transfer from the sensor to therapid-acting insulin smart cap (RCap) by waking up the pen cap andwaving it over the sensor, as shown in FIGS. 2 and 3.

After acquiring the glucose reading, the pen cap presents the user withtheir current glucose value and a trend line, along with a recommendedcorrection dose or action. If there is no glucose value available fromwithin the last ten minutes, the pen cap displays the home screen withno value and the system proceeds to the next step in the workflow wheninitiated by the user. In some embodiments, as discussed elsewhere, asuggested correction dose may be dependent on pen capping information.For example, in some embodiments, a recommended correction dose for anelevated glucose reading will only be displayed if the pen cap has beenon the pen for at least a threshold period of time (e.g., at least 2hours, at least 3 hours, or at least 4 hours). The time of the last dosemay be displayed, which would be based on the most recent capping of thepen cap.

FIG. 8 shows a correction dose recommendation process, according to anembodiment of the disclosure. In operation 402, detected removal of arapid-acting pen cap 122 (e.g., by a user) enables a recommendationmode. In one embodiment, the pen cap 122 may change from a low powermode to an active mode when then pen cap 122 is removed from an insulinpen. In one embodiment, while in the low power mode a pen cap maydisplay information about the last dosing action, for example, theamount of insulin and/or time of the last dose, such as shown at FIG. 3.In operation 404, the pen cap 122, responsive to the uncapping and beingwaived near the glucose monitor 130, enables an intermediate mode toread the glucose measurements from the glucose monitor 130, and sends aprompt to the user to swipe the pen cap 122 near the glucose monitor130. In one embodiment, the pen cap 122 may also enable a reader that isconfigured to interrogate the glucose monitor 130 when the pen cap 122is near. In one embodiment, the reader may be an NFC antenna thatadvertises itself as available for BLE communication. In one embodiment,a Bluetooth tag may be coupled to the glucose monitor 130 that maycommunicate with the reader responsive to the advertisement. Inoperation 406, the glucose monitor 130 provides the blood glucosemeasurements to the pen cap 122 responsive to an interrogation, and thepen cap 122 decodes the received measurements. In one embodiment, theglucose measurements may be encrypted or encoded using a proprietaryformat. In operation 408, the user pushes button 123 and the pen cap 122enables a correction dose recommendation mode responsive to the userasserting the button. In operation 410, the pen cap 122 recommends acorrection dose at a display on the pen cap 122. In one embodiment, thecorrection dose is determined at the pen cap 122. In another embodimentthe correction dose is determined at another device, such as the mobiledevice 140 and communicated to the pen cap 122. In various embodiments,the pen cap 122 may be configured to toggle back and forth between aglucose read mode and recommendation mode, and a user may be able toreceive current measurements and current recommendations. The pen cap122 may be configured to change back to a low power mode responsive to atime-out.

User Assessment of Glycemic Impact of Meal (Optional)

If the user intends to dose for a meal, they move to the next screen andare presented with three different dose recommendations, for meals thatwill have a small, medium, or large impact on their blood sugar. Theserecommendations may change over time to adapt to the user's habits andphysiology. The recommended doses include a correction based on theuser's glucose reading, if applicable.

Inject Rapid-Acting and Capture Insulin Dose

The user removes the RCap from the insulin pen and installs the needleonto the insulin pen. The needle is primed and then the user dials theirdesired dose and injects the insulin. The user removes the needle andreplaces the cap on the rapid-acting insulin pen. The glucose values (ifapplicable) are transmitted via BLE to the mobile app where they arestored locally on a smartphone. When a connection to the cloud isavailable via cellular or WiFi, the data is then synced to the cloud. Insome embodiments, a portion of the system (e.g., the cap, the mobileapplication) may monitor use of the pens (e.g., based on data inputtedby the user regarding usual use of the devices) to detect primingactions (e.g., clicks, such as two sets of clicks, from the pen and/orinput from the user regarding the priming or lack thereof) and/orselection of dosages. In some cases, methods, systems, and devicesprovided herein can detect a needle presence to infer priming behavior(i.e., assume priming if the needle was removed and replaced). In somecases, methods, systems, and devices provided herein can assume primingbased on dose volume and expected glucose impact.

FIG. 9 shows a rapid acting dose injection process according to anembodiment of the disclosure. In operation 422, the user activates themobile application and inputs meal information. In operation 424, themobile application presents one or more correction dose recommendationsto the user. In one embodiment, the recommendations are based on asliding scale of aggressiveness. In one embodiment, the recommendationsmay be based on a low, medium, or high glycemic impact of the mealinformation input by the user. In another embodiment, therecommendations may be based on a glucose reading and therecommendations may be based on a degree of confidence that the glucosereading is not too old. For example, if three recommendations arepresented, the first recommendation may correspond to a high degree ofconfidence that the last glucose reading is still valid. The secondrecommendation may correspond to a medium degree of confidence that lastglucose reading is still valid. The third recommendation may correspondto a low degree of confidence that the last glucose reading is stillvalid. In operation 426, the user uncaps the pen cap 122, which isdetected by the pen cap 122. In operation 428, the user primes theinsulin injection pen 120 to deliver a dose amount. In operation 430,the user injects a dose of insulin from the insulin injection pen 120.In operation 432, the user replaces the pen cap 122, which the pen cap122 detects. In operation 434, the pen cap 122 records the dose actionand time of dose action responsive to the detected capping event. Inoperation 436, the pen cap 122 returns to a low power mode responsive tothe capping event.

Delivering a Long-Acting Insulin Dose

When the user decides to deliver a long-acting insulin dose, the systeminitiates the following workflow. Some of the steps are optional and maynot be invoked if particular devices are unavailable or if the userchooses not to use them.

Acquire Glucose Reading

The user may initiate an NFC transfer from a glucose sensor (typically aCGM) to the long-acting insulin pen cap 112 by waking up the pen cap andwaving it over the sensor.

After acquiring the glucose reading, the pen cap presents the user withtheir current glucose value and a trend-line, along with a recommendedlong-acting insulin dose. If there is no glucose value available fromwithin the last ten minutes, the pen cap displays only the long-actinginsulin dose recommendation, which is tailored to the user's habits andphysiology and may change over time with clinician oversight andapproval.

FIG. 10 shows a correction dose recommendation process, according to anembodiment of the disclosure. In operation 442, a user removes a pen cap112 to enable a recommendation mode. The pen cap 112 may change from alow power mode to an active mode when then pen cap 112 is removed fromthe insulin pen. In one embodiment, while in the low power mode a pencap may display information about the last long acting insulin dosingaction, for example, the amount of insulin and/or time of the last dose,such as shown at FIG. 3. In operation 444, the pen cap 112, responsiveto the uncapping and being waived near the glucose monitor 130, enablesan intermediate mode to read the glucose measurements from the glucosemonitor 130, and sends a prompt to the user to swipe the pen cap 112near the glucose monitor 130. In one embodiment, the pen cap 112 mayalso enable a reader that is configured to interrogate the glucosemonitor 130 when the pen cap 112 is near. In one embodiment, the readermay be an NFC antenna that advertises itself as available for BLEcommunication. In one embodiment, a Bluetooth tag may be coupled to theglucose monitor 130 that may communicate with the reader responsive tothe advertisement. In operation 446, the glucose monitor 130 providesthe blood glucose measurements to the pen cap 112 responsive to aninterrogation, and the pen cap 112 decodes the received measurements. Inone embodiment, the glucose measurements may be encrypted or encodedusing a proprietary format. In operation 448, the user pushes button 113and the pen cap 112 enables a correction dose recommendation moderesponsive to the user asserting the button. In operation 450, the pencap 112 recommends a correction dose at a display on the pen cap 112. Inone embodiment, the correction dose is determined at the pen cap 112. Inanother embodiment the correction dose is determined at another device,such as the mobile device 140 and communicated to the pen cap 112. Invarious embodiments, the pen cap 112 may be configured to toggle backand forth between a glucose read mode and recommendation mode, and auser may be able to receive current measurements and currentrecommendations. The pen cap 112 may be configured to change back to alow power mode responsive to a time-out.

Inject Insulin Dose

The user removes pen cap 112 from the insulin pen and installs theneedle onto the cartridge. The needle is primed and then the user dialstheir desired dose and injects the insulin. The user removes the needleand replaces the cap on the rapid-acting insulin pen. The glucose values(if applicable) are transmitted via BLE to the mobile app where they arestored locally on a smartphone. When a connection to the cloud isavailable via cellular or WiFi, the data is then synced to the cloud. Insome embodiments, a portion of the system (e.g., the cap, the mobileapplication) may monitor use of the pens (e.g., based on data inputtedby the user regarding usual use of the devices) to detect primingactions (e.g., clicks, such as two sets of clicks, from the pen and/orinput from the user regarding the priming or lack thereof) and/orselection of dosages.

FIG. 11 shows a rapid-acting insulin injection process according to anembodiment of the disclosure. In operation 462, the user activates themobile application and inputs meal information. In operation 464, themobile application presents one or more correction dose recommendationsto the user. In one embodiment, the recommendations are based on asliding scale of aggressiveness. In one embodiment, the recommendationsmay be based on a low, medium, or high glycemic impact of the mealinformation input by the user. In another embodiment, therecommendations may be based on a glucose reading and therecommendations may be based on a degree of confidence that the glucosereading is not too old. For example, if three recommendations arepresented, the first recommendation may correspond to a high degree ofconfidence that the last glucose reading is still valid. The secondrecommendation may correspond to a medium degree of confidence that lastglucose reading is still valid. The third recommendation may correspondto a low degree of confidence that the last glucose reading is stillvalid. In operation 466, the user uncaps the pen cap 112, which isdetected by the pen cap 112. In operation 468, the user primes thelong-acting insulin injection pen 110 to deliver a dose amount. Inoperation 470, the user injects a dose of insulin from the insulininjection pen 110. In operation 472, the user replaces the pen cap 112,which the pen cap 112 detects. In operation 474, the pen cap 112 recordsthe dose action and time of dose action responsive to the detectedrecapping event. In operation 476, the pen cap 112 returns to a lowpower mode responsive to the capping event.

Checking Status on Rapid-Acting Pen Cap and Long-Acting Pen Cap

FIG. 12 shows a status check at the pen caps 112 and 122 according to anembodiment of the disclosure. By way of example, status information mayinclude the date and time of the last rapid-acting dose, a glucosetrend-line, most recent glucose reading and time, and recommendedcorrection doses. In operation 482 the user requests a status check fromthe pen cap 122 associated with rapid-acting insulin delivery. Inoperation 484, the user requests a status check from the pen cap 112associated with long acting insulin delivery. In operation 486, the pencap 122 may display the status information responsive to the user'srequest. In some embodiments, the pen cap 122 may persistently displaythe date and time of the last rapid-acting dose when it is in a lowpower mode. In operation 488, the pen cap 112 may display the statusinformation responsive to the user's request. In some embodiments, thepen cap 112 may persistently display the date and time of the last longacting dose when it is in a lower power mode.

Checking System Status

The user can check system status in the following locations:

FIG. 13 shows a status check at the mobile application according to anembodiment of the disclosure. By way of example, status information mayinclude system maintenance information (power remaining, insulinremaining, sensor status etc.) the date and time of the lastrapid-acting dose or long-acting dose, a glucose trend-line, most recentglucose reading and time, detailed forecasts and trends, and recommendedcorrection doses. In operation 492A, the user requests a status checkfrom the mobile application. In operation 494A, the mobile applicationmay display the status information responsive to the user's request.

FIG. 15 shows a process for checking the status of the system, accordingto an embodiment of the disclosure. In operation 522, the mobileapplication 104 is started. In operation 524, the mobile application 104presents a prompt for a user, the prompt being to scan the glucosesensor system. In one embodiment, the mobile application 104 may presentthe prompt responsive to a request received at the user interface tocheck system status. In operation 526, the mobile device running themobile application 104 is swiped near one or more glucose sensors. Inoperation 528, the mobile application 104 receives blood glucose datafrom the one or more glucose sensors. In operation 530, the mobileapplication 104 determines and presents glucose data and trends,typically for a recent time window.

Mobile Application User Interface

Methods and systems provided herein can additionally include a mobileapplication that runs on a mobile device (e.g., a smartphone or tablet)that is in wireless communication (e.g., via BLE) with one or more pencaps described herein. In some embodiments, blood glucose data may betransmitted from a glucose sensor system 101 (e.g., from a glucosemonitor 130 and/or a blood glucose meter 150), either via the pen capsand/or directly from the glucose sensor system. In some embodiments, amobile application can have a user interface that displays a graphicalrepresentation of the blood glucose data. In some embodiments, agraphical display of blood glucose data over time can include indicatorscommunicating pen capping information.

FIG. 16 shows an example display of the system (e.g., of the mobiledevice). For example, FIG. 16 shows an example user interface for amobile application that includes a graphical presentation of bloodglucose data with markings (e.g., triangles, circles, wedges, or anyother suitable icon or indication of a dose) along the x-axis showingthe timing of certain actions, such as, for example, re-capping actions,which may be assumed to be the timing of an insulin dosage, and/or otheractions, such as the timing of glucose readings. In some embodiments, ifan uncapping is prolonged (e.g., if the pen is left uncapped for a longperiod of time before the pen cap is re-capped), the triangle may bewider to indicate the time during which a dose of insulin might havebeen administered. In some embodiments, the icons may be different(e.g., different colors or shapes) depending on the type of insulinassociated with the pen cap that had a re-capping action. In someembodiments, a graphical presentation of blood glucose levels may betoggled between a 3 hour and a 12 hour time frame. In some embodiments,a home screen can include a simplified presentation of the current EGV,a curve shown prior to 30 minutes of the EGVs, and a curve showingprojected EGVs over the next 30 minutes.

Messages may be displayed on the home screen to provide the user withreminders about recommended actions that the user might take to improvetheir therapy. In some embodiments, a mobile app may provide coaching toa user based on a combination of the glucose data and/or pen cappinginformation. In some embodiments, coaching via the app may be approvedby a healthcare professional via a cloud connection before it isprovided to the user. For example, in some embodiments, blood glucosedata after a capping action may indicate that the user is typicallyunder dosing or typically over dosing insulin for particular meals. Insome embodiments, methods and systems provided herein can then adjustthe user-specific therapy parameters or recommended dose amounts forrapid-acting insulin based on blood glucose data after each cappingevent. In some embodiments, glucose data after or surrounding eachcapping event may be sent to a healthcare professional to have thehealthcare professional update user-specific dosage parameters orrecommended dose amounts for that user, which may be based on the timeof day. In some embodiments, data surrounding each capping event mayindicate that the user is typically dosing rapid-acting insulin afterthe meal has begun, and might be adapted to coach the user to pre-bolusfor meals when the user intends to eat. In some embodiments, datasurrounding each capping event along with blood glucose levels may beutilized to recommend injection timings relative to when a meal is begunafter the injection. In some embodiments, data surrounding each cappingevent and/or blood glucose levels may be utilized to recommend themodifications of doses of insulin taken by the subject. Again, suchcoaching may be automatic, approved by the healthcare professional,and/or developed by a healthcare professional.

In some embodiments, blood glucose levels may further be utilized totrack and/or make recommendations for the type of insulin being taken.In some cases, blood glucose levels may be analyzed in conjunction withdose capture data to determine if the wrong insulin was taken. In somecases, blood glucose data in combination with temperature sensor datafrom a pen cap may be analyzed to determine if the insulin has gone bad,if the wrong insulin was taken (e.g., as discussed above), or if thereare other issues with the therapy or associated devices.

The mobile application may be adapted to enable the user to provideadditional information that may be used to determine how often the useris following the recommended doses. In some embodiments, a user may beprovided with the possibility to input dose amounts for each cappingevent and/or may input multiple doses (e.g., an amount of insulin takenthroughout a selected period of time, such as, over a day) into themobile application or directly into the pen cap. For example, themarkings along the graph may be tapped by a user to allow a user toenter to dose administered.

FIG. 17 illustrates another example display 300 of a portion of thesystem (e.g., of the mobile device, such as mobile device 140 shown inFIG. 7). As shown in FIG. 9, the display 300 may somewhat similar tothat shown in FIG. 16 and may include a graphical presentation of bloodglucose data with markings (e.g., circles 302) along the x-axis showingthe timing of events relating to the system 10, such as, for example,the timing that glucose readings are received from an associated glucosemonitor (e.g., a flash monitor). The circles 302 may be connected by(e.g., may overlie) a trend line 304 of the user's blood glucose levels.

In embodiments where data is only intermittently received from a bloodglucose monitor (e.g., where segments or blocks of data regarding BGVsare downloaded at discrete time periods on demand), the data precedingthe current data point circle 302 indicating the latest glucose reading(e.g., the area between the current circle 302 and the immediatelypreceding circle 302) may be received from the glucose monitor andpopulated into the trend line 304. In some embodiments, another marker(e.g., a most recent circle 306) may be positioned at the latest reading(e.g., the most recent circle 302) and may be visually distinct from thepreceding circles 302. In some embodiments, the time of the last scanmay be displayed on the display 300. In some embodiments, the horizontalposition on the trend line 304 of the most recent circle or marker 306may also be indicated on the display 300 with a marker (e.g., verticalline 308).

In some embodiments, the pen cap may query the blood glucose sensor whenthe device is placed near the sensor and/or when a button (e.g., avirtual scan sensor button 310) is selected or pushed (e.g., and held)by a user. In some embodiments, the display 300 may include an indicator(e.g., meter 312 extending around the user button 310) that displays ameasurement related to the system. For example, the meter 312 maydisplay the remaining lifespan of the blood glucose sensor (e.g., theestimated time before the sensor needs to be replaced). As depicted, themeter 312 may increase (e.g., grow) or decrease (e.g., recede) aroundthe button 310 as the related data changes. For example, the meter 312may decrease or increase over time as the lifespan of the blood glucosesensor approaches zero (e.g., resulting in either a full meter 312 or anempty or outlined meter 312). In some embodiments, the meter 312 maydisplay other metrics, such as, for example, time since last scan, timeuntil next recommend scan, the percentage remaining of a previouslyadminister dose (e.g., a correction dose), etc.

As shown in FIG. 18, in some embodiments, the display 300 may enable theuser to track previous values on the trend line 304. For example, theuser may drag the most recent circle or marker 306 (e.g., along with thevertical line 308) backward along the trend line to a previous timeperiod. As depicted, the display 300 may track the position of the mostrecent circle 306 and display the time and blood glucose level of theselected time period.

In some embodiments, the most recent circle 306 (e.g., along with thevertical line 308) may be anchored to the most recent data position ofthe trend line 304 and may jump back to the most current position oncethe most recent circle 306 is released by the user. For example, thevertical line 308 may be deformed into a “slingshot” and spring thecircle 306 back to the most current reading position when released bythe user.

In some embodiments, a user might be asked to estimate a number of unitsof insulin remaining in a pen every so often. In some embodiments, auser might be asked to take a photo of the insulin pen and the app mightbe adapted to analyze the image of the insulin pen to determine anapproximate number of units left in the pen. For example, FIG. 19 showsan example user interface where a user might use the smartphone's camerato take a picture of the pen. In some embodiments, the user interfacemay overlay the real time view of the smartphone's camera with guidinglines that correspond to features on the pen in order to assist the userwith aligning the pen with the smartphone's camera. In some embodiments,the mobile app may be adapted to automatically snap a picture of the penwhen features in view of the smartphone's camera align with the guidinglines 152. As shown, the guiding lines 152 can include lines showingwindows in the pen that permit the viewing of plunger. In someembodiments, the guiding lines can move in relationship to the positionof the pen. In some embodiments, the mobile app can detect if the pen istoo close or too far away from the camera to instruct the user to movethe pen relative to the smartphone's camera. In some embodiments, thecamera can automatically zoom in on the pen. In some embodiments, a usermight be asked to estimate how often the user follows the recommendeddoses. In some embodiments, the device may automatically analyze theamount of insulin when the pen or a portion thereof is in view of themobile device (e.g., the camera).

In one embodiment, the device may automatically analyze an insulin vialand infer meal information based on changes to an image of the insulinvial. For example, based on several successive images meal intake andmeal times may be inferred based on changes in the amount of insulin ina vial and the type of insulin (i.e., rapid acting).

In some embodiments, the pen may include indicators e.g., graduatedmarkings) that enable a user to easily identify a position of a portionof the pen (e.g., the plunger) and input an associated value into theapplication.

Pen caps may be configured to gain insights into which recommended dosethe user is likely to be following. For example, as described in U.S.patent application Ser. No. 15/717,805, filed Sep. 27, 2017, entitled“Medicine Injection And Disease Management Systems, Devices andMethods,”, the contents and disclose of which is hereby incorporated byreference in its entirety, a pen cap (whether or not there is any dosecapture feature incorporated into the pen cap) can include mealannouncement categorizations (such as S, M, L) and data from eachannouncement might indicate whether the user is likely to have dosed anappropriate amount for a S, M, or L meal. In some embodiments, a buttonon pen cap 122 might be pressed multiple times to show recommendationsfor successively a S meal, a M meal, and a L meal, and methods andsystems provided herein may assume that the user dosed insulin based onthe last displayed recommendation. In some embodiments, informationadded via the mobile application indicating an amount of insulin left inthe pen at various intervals (once a day, once every few days, once aweek) can indicate whether the user is generally following the therapyrecommendations or whether the user is ignoring them. In someembodiments, methods and systems provided herein can analyze glucosedata, pen capping information, data regarding amounts of insulin left inone or more pens, and/or answers to questions presented via the mobileapp to determine a likelihood or rating of the user's conformance torecommended doses, which may be used by methods and systems providedherein to determine whether to adjust the recommended doses or toprovide coaching to the user.

System Setup

Therapy management systems provided herein may be setup using anysuitable method. In some embodiments, a health care professional caninput initial therapy parameters from a web portal or directly into auser's mobile device (e.g., during an appointment). In some embodiments,the user may input initial therapy parameters based on advice from adoctor. Therapy management systems provided herein provide a way forusers to clearly understand their therapy settings so that they gaintrust in the system.

FIG. 20 shows an example welcome screen in a mobile application of amobile device 140 for a diabetes management system, such as thosedepicted in FIG. 1A, 1B, or 1C. In the welcome screen, the user canclick a get started button to enter their settings, which might bedictated by a healthcare professional. The user may be given theopportunity to enter information relating to their insulin therapy(e.g., the brand and/or generic name of the long-acting and/orrapid-acting insulin, average dosage information, etc.). In someembodiments, a user may be asked to select long-acting insulin brandsand/or rapid-acting insulin brands from a list of known brands. In somecases, a user may also be asked about whether they use two insulin pensor one, and the product configuration may occur on the fly during setup.For example, some therapy settings may be automatically set responsiveto selected insulin brands. In some embodiments, prescriptioninformation may be associated with a pen cap (for example, downloadedfrom a therapy management system or entered by a medical provider), andlist of insulin brands may be curated based on the prescriptioninformation. Moreover, therapy settings may be automatically setresponsive to the prescription information.

The mobile application might present the screen shown in FIG. 21 wherethe user is asked to enter their daily dose of long-acting insulin(e.g., in whole or half units or other resolution based on theresolution of the user's long-acting insulin pen 110). The userinterface might use, for example, a sliding wheel or a number pad asshown. In some embodiments, the user might be asked to enter the time(or times) of the day when the user generally injects their long-actinginsulin. In another screen, such as shown in FIG. 22, the user can entertheir normal dosage amounts for differently sized meals. In someembodiments, each of these fields may be prefilled with a recommendedamount based on the user's daily dosage of long-acting insulin, whichmay be based on population models. For example, preset amounts may beprefilled based on a relationship as discussed in U.S. patentapplication Ser. No. 15/717,805, but the user interface can allow theuser to override these prefilled numbers by pressing in the fields toenter their own doses for each meal size. In some embodiments, themobile application can show the user examples of meals that fit eachcategory so that the user can compare their mental model regarding whatconstitutes a small meal, a medium meal, and a large meal to theassumptions of the system. FIG. 23 depicts an example user interface fordepicting example meals having a portion size that fit the differentcategories. For example, for the “Small Carbs” meal, each meal depictedwould have a similar glycemic impact (e.g., a similar carbohydrateamount). Likewise, the “Medium Carbs” meals and “Large Carbs” mealswould also have similar glycemic impacts (e.g., the same amount ofcarbohydrates) for those depicted in each category. For example, themeals depicted for “Small Carbs” could each include about 15-20 grams ofcarbohydrates, the meals depicted for “Medium Carbs” could each includebetween 35-45 grams of carbohydrates, and the meals depicted for “LargeCarbs” could each include between 60-80 grams of carbohydrates. Aftersetting the meal doses, the user can then select a glucose goal orglucose target range.

FIG. 24 depicts an example user interface where a user can upwardly ordownwardly adjust a glucose goal value. In some embodiments, the glucosegoal value can default to a preset number (e.g., 100 mg/dl, 80 mg/dl,120 mg/dl, etc.).

In the screen shown in FIG. 25, a user can review their settings (and,optionally, further adjust their settings).

Diabetes management systems provided herein can, in some embodiments,use data relating to the user to customize one or more correctionaldoses.

In some embodiments, a user interface on the mobile device 140 oravailable via the cloud from a remote server can permit a health careprofessional or a PWD to set an ISF or input other data use to determinecorrection doses. In some embodiments, a glucose goal value set in FIG.24 may be used along with an ISF (or increment value) input by or at thedirection of a health care professional to produce a linearsliding-scale correction chart. For example, the equation that mightdefine the linear sliding-scale correction chart would be as follows:Correction Dose=Rounddown(Current Blood Glucose−Glucose Goal)/ISF.

In some embodiments, the glucose goal set in FIG. 24 can define amidrange of a glucose target range and the equation can use the lowerbound of the glucose target range to calculate a correction dose. Insome embodiments, the ISF may be inferred from a mathematicalrelationship between the user's daily dosage of long-acting insulin.FIG. 26 depicts how a sliding scale chart may be determined by an ISF orinterval and a glucose goal or target. In some embodiments, a userinterface on the mobile application or in a web portal can generate asliding scale chart for the PWD, caregiver, or health care professionalto review before accepting the summary shown in FIG. 24. In someembodiments, a sliding scale chart may be included in the therapysummary. The sliding scale chart can simplify the user's understandingof how the system is adjusting their therapy based on real-time bloodglucose readings from the glucose sensor. In some embodiments, a userinterface may use a slider to enable a user to update the increment orthe start and to have the generated sliding scale correction chartdynamically update in order to enable a health care professional or PWDhave the generated chart match their desired therapy settings (e.g., asshown in FIG. 33).

FIGS. 27 through 30 depict different options that may be presented tothe user via a user interface to enable the mobile application to createa sliding scale (e.g., as shown above in FIG. 18. As shown in FIG. 27,as a first option, the mobile application may prompt the user (e.g., thesubject and/or a caregiver) to enter values relating to actions (e.g.,based on historical use) taken by the subject while managing bloodglucose levels. For example, historical data relating to the amount(e.g., units) of insulin (e.g., rapid-acting insulin) taken in responseto a certain blood glucose level range. As shown in FIG. 28, more thanone range may be inputted to create a user-inputted scale, which may be(e.g., result in) a non-linear scale.

As shown in FIG. 29, as a second option, the mobile application mayprompt the user to directly enter values relating to the ISF of thesubject. For example, the user may enter the average drop in bloodglucose level, measured in milligrams per deciliter (mg/dl), caused byeach unit of insulin taken by the subject. In some embodiments, themobile application may enable the user to enter a target blood glucoselevel.

In either option, the mobile application may display a confirmation ofthe scale (e.g., non-linear scale) entered manually by the user underthe first option or a confirmation of the scale (e.g., a linear scale)generated using the ISF value entered by the user under the secondoption.

Methods, devices, and systems provided herein may detect patterns inblood glucose levels and/or patterns of injections that enable thedevices or systems to understand the impact of dosing and determinerecommended therapy setting changes to improve glycemic outcomes. Insome embodiments, the mobile device can determine appropriate therapychanges. In some embodiments, a remote server can determine appropriatetherapy settings. In some embodiments, methods, devices, and systems canincrementally automatically adjust dosages for different meal sizes asdescribed in U.S. patent application Ser. No. 15/717,805, which ishereby incorporated by reference. In some embodiments, algorithms canupdate the ISF or the correction doses based on detected patterns. Insome embodiments, methods, devices, and systems can determine if thereis a therapeutically relevant change recommended and then use thatinformation to tell the user about the pattern or to tell the user aboutthe pattern with a trigger, a tip, or a suggestion to the user e.g., amessage in the mobile application); examples of which are depicted inFIG. 31. For example, messages might be as shown in FIG. 31 and/ordisplayed on the mobile device as shown in FIG. 32. As shown in FIG. 32the message might include a button to bring the user to a screen thatshows the user how to make an appropriate change (e.g., in-app training)and/or to a screen to actually make the change. Pressing this buttonmight bring the user to a screen shown in FIG. 33, which includes aplurality of sliders for each meal size. In some embodiments, the usermight elect to just change the size of one meal or might desire tochange things across the board by changing the bottom slider. In someembodiments, changing the bottom slider might change an ISF value. Insome embodiments, the settings may be based on time of day (e.g.,breakfast time, lunch time, dinner time) and a user can adjust thesettings particularly for one of those meal times or all of those mealtimes.

Alerts and Alarms

In some embodiments, diabetes management systems, devices, and methodsprovided herein may provide notifications, alarms, and/or alerts. Insome embodiments, notifications, alarms, and/or alerts may beautomatically triggered on one or more portions of the system, such as,for example, the mobile device, the pen caps, and/or one or moreseparate alert accessories. In some embodiments, therapy managementsystems, devices, and methods provided herein can include a smart pen orpen accessory (e.g., an accessory adapted to be secured to a pen, suchas, for example, a pen cap and/or another accessory that is integralwith or may be applied and/or coupled to the pen) that is adapted toprovide notifications, therapy recommendations, and/or alerts upon theuser taking action to retrieve blood glucose data. In some embodiments,therapy management systems, devices, and methods provided herein caninclude both one or more alert accessories and one or more smart pens orpen accessories that can each wirelessly receive blood glucose data(e.g., from a continuous glucose monitor). In some embodiments, therapymanagement systems, devices, and methods provided herein may have one ormore smart pens or pen accessories that communicate with a blood glucosemonitoring system (e.g., a continuous glucose monitor) via a firstcommunication technique (e.g., NFC) and have one or more alertaccessories that communicate with a blood glucose monitoring system(e.g., the same continuous glucose monitor) via a second communicationtechnique (e.g., UHF, BLE). In some embodiments, the communicationtechnique for communicating blood glucose data to the alert accessoryhas a larger range than the communication technique for communicatingblood glucose data to the smart pens or pen accessories. In someembodiments, therapy management systems, devices, and methods providedherein can include one or more alert accessories that passively receiveblood glucose data (e.g., via wireless communication), provided that itis in a communication range, and one or more smart pens or penaccessories that are configured to only wirelessly receive blood glucosedata if a user takes action to have the smart pen or pen accessoryreceive blood glucose data (e.g., presses a button, swipes the pen orpen accessory adjacent to a glucose sensor, etc.). In some embodiments,having a smart pen or pen accessory that only receives blood glucosedata upon user action can reduce the power consumption for the smart penor pen accessory, thus reducing the burden on the user to recharge orreplace batteries in the smart pen or pen accessory. In someembodiments, having an alert accessory as provided herein can enable theuser to decide when and where to receive disruptive alarms, alerts, andnotifications, and further permit the user to not feel a need to carryaround their insulin pens between doses.

Methods, systems, and devices provided herein can include one or morealert accessories that can take any suitable form. In some embodiments,an alert accessory can include one or more illuminable icons. In someembodiments, an alert accessory can include a digital display screen. Insome embodiments, an alert accessory can include one or more speakersand/or vibrational motors. In some embodiments, alert accessoriescontemplated herein may be secured to a smartphone (e.g., as a phonecase). In some embodiments, alert accessories contemplated herein may besecured to a keychain. In some embodiments, alert accessoriescontemplated herein may be adapted to serve as a bedside alarm clock. Insome embodiments, alert accessories are contemplated herein.

In some embodiments, methods, systems, and devices provided herein mayprovide guidance regarding an appropriate dosage of insulin. In someembodiments, the dosage of insulin may be administered with an insulindelivery pen or syringe. In some embodiments, the insulin may belong-acting insulin. In some embodiments, the insulin may berapid-acting insulin. In some embodiments, an insulin delivery pen, oraccessory therefor (e.g., a cap), can detect an amount of insulindelivered from the pen (or an amount of insulin that was set fordelivery). In some embodiments, an insulin pen, or an accessorytherefor, can include a user-interface, which can display data orrecommendations to the user and/or permit the user to enter data intothe insulin pen or accessory.

The following example therapy management system includes insulindelivery pens having dose-capture pen caps, but other embodiments areenvisioned where the functionality disclosed herein is incorporated intoother accessories for an insulin delivery pen or the insulin deliverypen itself. Additionally, the following example therapy managementsystem includes a single alert accessory (e.g., a CGM fob), but otherembodiments are envisioned that include multiple alert accessories orwhere the functionality of the alert accessory is merged into asmartphone or other web-connected mobile computing device (e.g., usingWiFi or cellular communications).

In some embodiments, one or more portions of the system (e.g., the pens,the mobile application, the alert accessory) may be configured topresent one or more of the following alarms or alerts:

-   -   Glucose Alerts: low glucose, high glucose, high likelihood of        low glucose in the future, high likelihood of high glucose in        the future, high glycemic variability    -   Timing Alerts: alerts to check blood glucose (e.g., for a        specific diurnal time segment), alerts for meal timing, pen        uncapped for a certain duration, double doses (e.g. pen uncapped        twice in a short time period)    -   Rapid-acting Insulin Alerts: take correction dose, missed        rapid-acting dose, dangerous rapid-acting dose, dose exceeding        threshold    -   Long-acting Insulin Alerts: take long-acting dose, missed        long-acting dose, dangerous long-acting dose, dose exceeding        threshold    -   Switched Insulin Alerts: dangerous dose taken—switched doses,        wrong pen cap    -   Temperature Alerts: out of range conditions of the insulin        detected, as discussed above    -   Maintenance Alerts: out of insulin, low power, sensor failure,        sensor expired

In some cases, methods and systems provided herein include an alarm oralert that is triggered if a user removes a long acting pen cap or rapidacting pen cap during a time period when a user should not (or shouldadminister a different dose) administer long-acting insulin orrapid-acting insulin. For example, when an uncapping of a long-actingpen cap is detected, then insulin dose information about a recent doseof long-acting insulin may be reviewed. Reviewed dose information mayinclude dose amount, dose time, type of insulin, and/or brand ofinsulin. Based on dose information and uncapping information, a risk ofa user mistake may be inferred. Examples of user mistakes for which arisk may be inferred include, but are not limited to, administering adose of long acting insulin instead of rapid acting insulin andadministering a dose of long acting insulin and/or rapid acting insulintoo soon after a previous dose. So, a contemplated operation of methodsand systems of this disclosure includes, for example, an uncapping eventis detected for a long acting pen cap at 9:30 AM. Dosing eventscorresponding to inferred dosing actions (e.g., based on capping eventsas described herein) are reviewed and a dosing event for long actinginsulin at 8:00 AM is identified. Dosing information indicates that adose of long acting insulin was administered at 8:00 AM, the amount ofinsulin administered corresponds to a basal dose, and a risk of a usermistakenly administering a second dose of long acting insulin isinferred (such a risk may also be characterized as a risk of insulinstacking). In some cases, the earlier dose may be confirmed based onblood glucose data, changes in which would be indicative of insulinaction on a user's blood glucose levels. Upon inferring the risk of auser mistakenly administering long acting insulin, an alarm or alert maybe generated and presented to a user. For example, a pen cap, injectionpen, or mobile device may vibrate or emit an audible sound indicating toa user that there may be an error.

d

Upgradable System

Diabetes management systems provided herein may be adapted to add orremove components from use and/or to be configured based on the needs ofthe person with diabetes (PWD). For example, FIGS. 34A-34D illustratedifferent systems and the associated communication architecture thatpermit use for PWDs having different types of diabetes (Type 1 or Type2, as shown, or additionally including gestational diabetes or othertypes of diabetes), different progressions of diabetes, and/or differentpreferences for how to monitor and/or treat their diabetes. In somecases, methods and devices provided herein may be adapted determine whenadditional therapies are warranted and recommend the addition ofadditional therapies or devices to the therapy and/or the system.

FIG. 34A depicts a system 3410 that includes only a BGM 150, a mobiledevice 140 having a mobile app, a long-acting insulin injection pen 110,and a long-acting pen cap 112. System 3410 can communicate with cloud orweb services 250 via mobile device 140 as discussed above. System 3410may be adapted for use by PWDs that do not require meal time insulin(e.g., early progression of type 2 diabetes and/or gestational diabetes)or PWDs that do not want rapid-acting insulin doses to be tracked. BGM150 is a blood glucose meter adapted to determine estimated glucosevalues (EGVs) through the use of test strips that analyze in-vitro bloodsamples. As shown, BGM 150 can transmit single-point EGVs to pen cap 112via BLE communications link 3401. The EGVs from BGM 150 can then betransmitted from pen cap 112 to mobile device 140 via BLE communicationslink 3405, and via mobile device 140 to cloud or web services 250 foranalysis via network communications link 3409. BLE communications link3405 can also transmit pen capping data to mobile device 140, which canalso be transmitted via link 3409 to web services 250. Mobile device 140can display the most recent EGVs and/or a graph of collected EGVs.Recommended doses of long-acting insulin may be displayed on pen cap 112in a manner similar to that shown in FIG. 6 and in FIG. 35A. System 3410can prompt a use to collect fasting EGVs with BGM 150. System 3410 canuse fasting EGVs to recommend changes or automatically make change tothe displayed recommended doses of long-acting insulin using standardlong-acting insulin titration techniques or any other suitablealgorithm. In some cases, algorithms may be used in system 3410 todetermine if a PWD should add rapid-acting insulin to their therapy.

FIG. 34B depicts a system 3420 that includes the components of system3410 but adds a rapid-acting insulin pen 120, and a rapid-acting pen cap122. System 3420 may be adapted for use by PWDs that require both long-and rapid-acting insulin but that wish to monitor EGVs with a BGMinstead of a continuous or flash glucose monitor. When the rapid-actingpen cap is added to the system, communication link 3401 is eliminatedand long-acting pen cap 112 does not receive EGVs from BGM 150 as BGMvalues are not used in real time to determine an instant dose oflong-acting insulin, but may be used to determine a correction dose ofrapid-acting insulin. As shown, BGM 150 can transmit single-point EGVsto pen cap 122 via BLE communications link 3402. The EGVs from BGM 150can then be transmitted from pen cap 122 to mobile device 140 via BLEcommunications link 3406, and via mobile device 140 to cloud or webservices 250 for analysis via network communications link 3409. BLEcommunications links 3405 and 3406 can also transmit pen capping data tomobile device 140, which can also be transmitted via link 3409 to webservices 250. Mobile device 140 can display the most recent EGVs and/ora graph of collected EGVs. Recommended doses of rapid- and long-actinginsulin may be displayed on pen cap 112 in a manner similar to thatshown in FIGS. 3-6 and in FIGS. 35A and 35B. System 3420 can prompt ause to collect fasting and/or post-prandial EGVs with BGM 150. Forexample, system 3420 can in some cases trigger reminders to a user tocheck an EGV at a predetermined time after a pen capping event tocollect post-prandial EGVs. System 3420 can use fasting EGVs torecommend changes or automatically make change to the displayedrecommended doses of long-acting insulin using standard long-actinginsulin titration techniques or any other suitable algorithm. System3420 can use post-prandial EGVs to recommend changes or automaticallymake change to the displayed recommended doses of rapid-acting insulinusing standard insulin titration techniques or any other suitablealgorithm. In some cases, algorithms may be used in system 3420 todetermine if a PWD should add a continuous glucose monitor to help thePWD achieve better glycemic control.

FIG. 34C depicts a system 3430 that includes the components of system3420 but adds a continuous glucose monitor 130. CGM 130 can enable bothbroadcast data via BLE or UHF radio and user-initiated data transfersvia NFC communications, according one or both methods of communicationmay be used to transmit EGVs from CGM 130 to pen cap 122 and/or mobiledevice 140. No direct communication between CGM 130 and pen cap 112 isrequired because long-acting doses of insulin do not use a correctioncomponent. For example, NFC communication link 3403 can allow for pencap 122 to receive EGVs from CGM 130 upon a user's decision to retrieveEGVs, such as by using a method depicted in FIG. 2 and discussed above.BLE communication link 3402 still permit the transfer of EGVs from BGM150 to pen cap 122. The EGVs from BGM 150 and/or CGM 130 can then betransmitted from pen cap 122 to mobile device 140 via BLE communicationslink 3406, and via mobile device 140 to cloud or web services 250 foranalysis via network communications link 3409. Additionally, EGVs fromCGM 130 may be received by the mobile device 140 via communication link3404, which can include both BLE and NFC communications. Broadcast BLEEGVs may be used to trigger EGV-based alarms or alerts announced fromthe mobile device 140. Missed EGVs may be filled in by scanning the CGM130 the mobile device 140 or pen cap 122 to get multiple hours of priorEGV data (e.g., 4 hours, 6 hours, 8 hours, or 10 hours). BLEcommunications links 3405 and 3406 can also transmit pen capping data tomobile device 140, which can also be transmitted via link 3409 to webservices 250. Recommended doses of rapid- and long-acting insulin may bedisplayed on pen cap 112 in a manner similar to that shown in FIGS. 3-6and in FIGS. 35A and 35B. System 3430 can use EGV data in combinationwith dose data (e.g., timing data) to recommend changes or automaticallymake change to the displayed recommended doses of rapid-acting insulinusing standard insulin titration techniques or any other suitablealgorithms.

FIG. 34C also indicates that a system 3440 can also include the samecomponents. System 3440 differs from system 3430 in that it includes pencaps 112 and 122 adapted to detect amounts of insulin remaining ininsulin pens 110 and 120, which may be used to determine dose amounts ofinsulin. Other methods may be used to detect doses, either in caps orother accessories or as part of a smart pen or smart inhaler, and arethus contemplated herein. Additionally, system 3440 may use captureddose data to more aggressively automate changes to user-specific dosageparameters.

FIG. 34D illustrates the continuum of care and how components may beadded to each system 3410-3440 to upgrade the system. Additionally,system 3450 is an automated insulin delivery system using an insulinpump. In some cases, the use of system 3440 or 3430 may detectcandidates for switching to pump therapy, such as system 3450. In somecases, system 3450 can include pen caps 112 and/or 122, which can allowa user to selectively move between an injection therapy (e.g., MDItherapy) and a pump therapy (e.g., infusion pump therapy).

FIG. 35A illustrates example displays 114A-114C for pen cap 112. FIG.25B illustrates example displays 124A-124E for pen cap 122. For pen cap112, display 114A may be the standard display when the pen cap is not inuse. As discussed above, the display 114 may be a bistable display thatcan retain an image without excessive power supply. Display 114A caninclude a label of the type of insulin so that a user glancing at thepen cap 112 will immediately know the type of insulin. When a button ispressed or the pen cap 112 removed a time of a last dose may bedisplayed in display 114B. In some cases, if the time since the lastdose is less than a threshold (e.g., less than 12 hours), a warning mayappear and/or the pen cap may refuse to provide a recommended dose. Indisplay screen 114C, a recommended dose amount is shown.

For pen cap 122, display 124A may be the standard display when the pencap is not in use. As discussed above, the display 124 may be a bistabledisplay that can retain an image without excessive power supply. Display124A can include a label of the type of insulin so that a user glancingat the pen cap 122 will immediately know the type of insulin. When abutton is pressed or the pen cap 122 removed a time of a last dose maybe displayed in display 124B. A retrieval of an EGV (e.g., via a scan ofCGM 130) can cause display 124C to appear. As shown, display 124Cincludes a correction dose, which may be based on the EGV (andoptionally trend data) using any suitable technique. In some cases, thecorrection dose may only appear if a time since the prior dose isgreater than a predetermined number of hours and the pen cap 122 isstill on the pen 120. In some cases, if the time since the last dose isless than a threshold (e.g., less than 1 hour, less than 30 minutes), awarning may appear and/or the pen cap may refuse to provide arecommended dose. In display screen 124D, meal dose recommendations areshown. In display screen 124E, meal+correction doses are shown. In somecases, display 124 can progress through display screens 124C-124E withsuccessive button pushes.

The embodiments described herein may include the use of aspecial-purpose or general-purpose computer including various computerhardware or software modules, as discussed in greater detail below.

Embodiments described herein may be implemented using computer-readablemedia for carrying or having computer-executable instructions or datastructures stored thereon. Such computer-readable media may be anyavailable media that may be accessed by a general-purpose orspecial-purpose computer. Special-purpose computer is intended to beinterpreted broadly and encompasses embedded systems, microcontrollers,application specific integrated circuits, digital signal processors, andgeneral-purpose computers programmed for specific purposes. Segments(e.g., code segment or data segment) may refer to a portion (e.g.,address) of memory, virtual memory, or an object file.

By way of example, and not limitation, such computer-readable media mayinclude non-transitory computer-readable storage media including RandomAccess Memory (RAM), Read-Only Memory (ROM), Electrically ErasableProgrammable Read-Only Memory (EEPROM), Compact Disc Read-Only Memory(CD-ROM) or other optical disk storage, magnetic disk storage or othermagnetic storage devices, flash memory devices (e.g., solid-state memorydevices), or any other storage medium which may be used to carry orstore desired program code in the form of computer-executableinstructions or data structures and which may be accessed by ageneral-purpose or special-purpose computer. Combinations of the abovemay be included within the scope of computer-readable media.

Computer-executable instructions comprise, for example, instructions anddata which cause a general-purpose computer, special-purpose computer,or special-purpose processing device (e.g., one or more processors) toperform a certain function or group of functions. Although the subjectmatter has been described in language specific to structural featuresand/or methodological acts, it is to be understood that the subjectmatter defined in the appended claims is not necessarily limited to thespecific features or acts described above. Rather, the specific featuresand acts described above are disclosed as example forms of implementingthe claims.

Any ranges expressed herein (including in the claims) are considered tobe given their broadest possible interpretation. For example, unlessexplicitly mentioned otherwise, ranges are to include their endpoints(e.g., a range of “between X and Y” would include X and Y).Additionally, ranges described using the terms “approximately” or“about” are to be understood to be given their broadest meaningconsistent with the understanding of those skilled in the art.Additionally, the terms “approximately” or “substantially” includeanything within 10%, or 5%, or within manufacturing or typicaltolerances.

The features of the various embodiments described herein are notmutually exclusive and can exist in various combinations andpermutations, even if such combinations or permutations are notexpressly described herein, without departing from the scope of thedisclosure. In fact, variations, modifications, and otherimplementations of what is described herein will occur to one ofordinary skill in the art without departing from the scope of thedisclosure. As such, the invention is not to be defined only by thepreceding illustrative description, but only by the claims which follow,and legal equivalents thereof.

Additional non-limiting embodiments of the disclosure relate, generallyto a pen cap for insulin injection pens and associated methods andsystems:

Embodiment 1

A pen cap for a manual insulin delivery device, comprising: a wirelesscommunication interface configured to receive blood glucose data from aglucose sensor system; at least one detection circuit configured todetect one or more cappings and one or more decappings of the pen capfrom the manual insulin delivery device; at least one user interfaceconfigured to present one or more of therapy relevant information,therapy recommendations, and timing information associated with detectedcappings or detected decappings of the pen cap; and a processor and amemory, the memory comprising: a data segment configured to store one ormore of at least one user-specific dosage parameter and a recommendeddose; and a code segment configured to store instructions that, whileexecuted by the processor, are adapted to enable the processor todetermine content presentable by the at least one user interfaceresponsive to the timing information associated with detected cappingsor detected decappings of the pen cap.

Embodiment 2

The pen cap of Embodiment 1, wherein the user interface is configured topresent a recommended correction dose of insulin responsive to adetermination that the replacement cap has been capped on the manualinsulin delivery device for at least a threshold period of time, whereinthe recommendation correction dose of insulin is based on an insulinsensitivity factor and target glucose value stored at the data segmentof the memory.

Embodiment 3

The pen cap of any one of the preceding Embodiments, wherein thewireless communication interface is configured to communicate with theglucose sensor system via a near field communication protocol when inproximity to at least one part of the glucose sensor system.

Embodiment 4

The pen cap of any one of the preceding Embodiments, wherein thewireless communication interface is configured to transmit messages thatare associated with an insulin therapy.

Embodiment 5

The pen cap of any one of the preceding Embodiments, wherein themessages comprise indicators, and the indicators are associated with theinsulin therapy.

Embodiment 6

The pen cap of any one of the preceding Embodiments, wherein themessages are configured to be received by one or more insulin therapyapplications executing at one or more mobile computing devices.

Embodiment 7

The pen cap of any one of the preceding Embodiments, wherein thewireless communication interface is configured to transmit messages bybroadcasting advertising messages.

Embodiment 8

The pen cap of any one of the preceding Embodiments, wherein thewireless communication interface is configured to transmit messagesusing data transmission.

Embodiment 9

The pen cap of any one of the preceding Embodiments, wherein wirelesscommunication interface is configured to automatically transmit data toninsulin therapy application executing on a mobile device.

Embodiment 10

The pen cap of any one of the preceding Embodiments, wherein thewireless communication interface is configured to automaticallycommunicate with the mobile application.

Embodiment 11

The pen cap of any one of the preceding Embodiments, wherein thewireless communication interface is adapted to communicate with theglucose sensor system using a first wireless communication techniquehaving a first communication range and the wireless communicationinterface is adapted to communicate with the mobile computing deviceusing a second wireless communication technique having a secondcommunication range, the second communication range being greater thanthe first communication range.

Embodiment 12

The pen cap of any one of the preceding Embodiments, wherein the glucosesensor system comprises a flash glucose monitor.

Embodiment 13

The pen cap of any one of the preceding Embodiments, wherein the contentincludes a representation of a percentage of active insulin remainingwithin a user based on a time of a previous capping or decapping of thereplacement pen cap and a current time.

Embodiment 14

The pen cap of any one of the preceding Embodiments, wherein the codesegment is configured to store instructions that, while executed by aprocessor, are adapted to enable the processor to: determine an amountof insulin remaining in the manual insulin delivery device; anddetermine a dose amount for a time of a previous capping or decapping,and wherein the at least one user interface is configured to display anestimation of active insulin remaining within a user responsive to acurrent time and one or more dosing events.

Embodiment 15

The pen cap of any one of the preceding Embodiments, wherein the memorysegment is configured to store dosing events over a first time period,the time period comprising: a first block of discrete time units; astart time unit of the first block of discrete time units; and an endtime of the first block of discrete time units, and wherein the end timecorresponds to the current time and at least one of the discrete timeunits is associated with a dosing event of the dosing events.

Embodiment 16

The pen cap of any one of the preceding Embodiments, wherein the codesegment is configured to store instructions that, while executed by theprocessor, are adapted to enable the processor to record dosing eventsresponsive to detected capping and/or detected decapping and associatethe dosing events with one or more discrete time units of the discretetime units.

Embodiment 17

The pen cap of any one of the preceding Embodiments, wherein the codesegment is configured to store instructions that, while executed by theprocessor, are adapted to enable the processor to: select a block ofdiscrete time units that form the first time period responsive to anactive insulin estimation request and the current time; select the oneor more dosing events that are associated with the first time period;determine the estimation of active insulin remaining within the userresponsive to the current time and the one or more dosing events.

Embodiment 18

The pen cap of any one of the preceding Embodiments, wherein the atleast one user interface is configured to display the estimation ofactive insulin remaining as a percentage of a dose amount associatedwith a most recent dosing action.

Embodiment 19

The pen cap of any one of the preceding Embodiments, further comprisingan inner sleeve and an outer housing, the inner sleeve and the outerhousing defining a water tight cavity.

Embodiment 20

The pen cap of any one of the preceding Embodiments, wherein at least apart of one or more of the at least one detection circuit, processor,memory, and wireless communication interface is retained within thewater tight cavity.

Embodiment 21

The pen cap of any one of the preceding Embodiments, further comprisingan adapter configured to reversibly couple with a corresponding adapterat the manual insulin delivery device.

Embodiment 22

An insulin delivery system comprising: an insulin injection pen fordelivering insulin; and a pen cap adapted to be reversibly secured tothe insulin injection pen, the pen cap comprising: a wirelesscommunication interface adapted to receive blood glucose data from aglucose sensor system; at least one circuit adapted to detect onewhether the pen cap is secured to the insulin injection pen; and atleast one user interface to communicate therapy relevant information,therapy recommendations, or a time of a previous capping or decapping ofthe pen cap from the insulin injection pen; memory to store at least oneuser-specific dosage parameter or recommended dose; and at least oneprocessor adapted to determine content presented by the user interface,the at least one processor using information about one or more cappingor decapping to determine the content.

Embodiment 23

The insulin delivery system of Embodiment 22, wherein the user interfaceis adapted to display a recommended correction dose of insulin based onan insulin sensitivity factor and target glucose value stored in memoryif the pen cap has been capped on the insulin injection pen for at leasta threshold period of time.

Embodiment 24

The insulin delivery system any one of the preceding Embodiments,wherein the content includes a representation of a percentage of activeinsulin remaining within a user based on a time of a previous capping ordecapping of the pen cap and a current time.

Embodiment 25

The insulin delivery system of any one of the preceding Embodiments,wherein the replacement pen cap is adapted to determine an amount ofinsulin remaining in the insulin injection pen and determine a doseamount for the time of a previous capping or decapping, wherein the pencap displays an estimation of active insulin remaining within the userbased a current time and the times and dose amounts associated with oneor more a previous capping or decapping of the pen cap.

Embodiment 26

A diabetes management system comprising: a mobile computing deviceconfigured to receive one or more user-specific dosage parameters orpredetermined doses from a user; a glucose sensor system configured tocollect and wirelessly transmit blood glucose data; and a pen capadapted to be reversibly secured to an insulin injection pen, the pencap comprising: a wireless communication interface adapted to receivethe blood glucose data from the glucose sensor system and the one ormore user-specific dosage parameters or predetermined doses from themobile computing device; at least one circuit adapted to detect onewhether the pen cap is secured to the insulin injection pen; and atleast one user interface to communicate therapy relevant information,therapy recommendations, or a time of a previous capping or decapping ofthe pen cap from the insulin injection pen; memory to store the one ormore user-specific dosage parameters or predetermined doses receivedfrom the mobile computing device; and at least one processor adapted todetermine content presented by the user interface, the at least oneprocessor using information about one or more capping or decapping todetermine the content.

Embodiment 27

The diabetes management system of Embodiment 26, further comprising aninsulin injection pen adapted to be reversibly secured to the pen cap.

Embodiment 28

The diabetes management system of any one of the preceding Embodiments,wherein the user interface is adapted to display a recommendedcorrection dose of insulin based on an insulin sensitivity factor andtarget glucose value stored in memory if the replacement pen cap hasbeen capped on the insulin injection pen for at least a threshold periodof time.

Embodiment 29

The diabetes management system of any one of the preceding Embodiments,further comprising a long-acting insulin pen, a rapid-acting insulinpen, and at least two pen cap, the at least two of the pen capsincluding a first pen cap adapted to be secured to the long-actinginsulin pen and a second pen cap adapted to be secured to therapid-acting insulin pen.

Embodiment 30

The diabetes management system of any one of the preceding Embodiments,wherein the wireless communication interface is configured tocommunicate with the glucose sensor system via a near fieldcommunication protocol when the pen cap is positioned in proximity to atleast one part of the glucose sensor system.

Embodiment 31

The diabetes management system of any one of the preceding Embodiments,wherein the wireless communication interface is adapted to communicatewith the glucose sensor system using a first wireless communicationtechnique having a first communication range and the wirelesscommunication interface is adapted to communicate with the mobilecomputing device using a second wireless communication technique havinga second communication range, the second communication range beinggreater than the first communication range.

Embodiment 32

The diabetes management system of any one of the preceding Embodiments,wherein the glucose sensor system comprises a flash glucose monitor.

Embodiment 33

A smart electronics module integratable with a manual insulin deliverydevice, comprising: a wireless communication interface configured toreceive blood glucose data from a glucose sensor system; at least onedetection circuit configured to detect one or more cappings and one ormore decappings of a pen cap from the manual insulin delivery device; atleast one user interface configured to present one or more of therapyrelevant information, therapy recommendations, and timing informationassociated with detected cappings or detected decappings of the pen cap;and a processor and a memory, the memory comprising: a data segmentconfigured to store one or more of at least one user-specific dosageparameter and a recommended dose; and a code segment configured to storeinstructions that, while executed by the processor, are adapted toenable the processor to determine content presentable by the at leastone user interface responsive to the timing information associated withthe detected cappings or detected decappings of the pen cap.

Embodiment 33

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data is an interstitial fluidglucose level or based on an interstitial fluid glucose level.

Embodiment 34

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data is a blood glucose levelcorrelated to an interstitial fluid glucose level.

Embodiment 35

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data is a blood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to therapy management systems, methods, and devices:

Embodiment 1

A reusable accessory for a manual medication delivery device,comprising: a wireless communication interface that is configured toreceive analyte measurement data from an analyte sensor system;detection circuitry configured to: detect dosing events associated withdosing actions at the manual medication delivery device; and store arecord for each of the one or more dosing events, wherein the recordcomprises a dosing time of the dosing events; a recommendation systemconfigured to provide one or more medication dose recommendationsresponsive to one or more of the analyte measurement data and the dosingevents; and an adapter configured to reversibly couple to apredetermined portion of the manual medication delivery device.

Embodiment 2

The reusable accessory of Embodiment 1, wherein the manual medicationdelivery device is a medication injection pen and the reusable accessoryis a reusable pen cap for the medication injection pen, and wherein thedosing events associated with the one or more dosing actions are one ormore of capping events or decapping events, and the detection circuitryis configured detect capping events or decapping events responsive tosensor signals.

Embodiment 3

The reusable accessory of any one of the preceding Embodiments, furthercomprising a timer configured to count a number of time units from adecapping event to a subsequent capping event, wherein the circuitry isconfigured to record a dose time responsive to a determined countgreater than a threshold number of time units.

Embodiment 4

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface is configured to receive theanalyte measurement data over a first wireless connection when thewireless communication interface is positioned in proximity to at leasta portion of the analyte sensor system.

Embodiment 5

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface is configured to communicate, overa second wireless connection, dosing events, therapy parameters, andanalyte measurement data with a mobile computing device.

Embodiment 6

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface is configured to receive therapyparameters from the mobile computing device.

Embodiment 7

The reusable accessory of any one of the preceding Embodiments, whereinthe first wireless connection has a first communication range and thesecond wireless connection has a second communication range, wherein thesecond communication range is greater than the first communicationrange.

Embodiment 8

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface comprises an NFC chip and the firstwireless connection consists of NFC communications between the reusableaccessory and the analyte sensor system.

Embodiment 9

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface comprises a wireless radio adaptedto enable BLUETOOTH Low Energy communication between the reusableaccessory and one or more mobile computing devices.

Embodiment 10

The reusable accessory of any one of the preceding Embodiments, whereinthe analyte sensing system comprises a blood glucose meter adapted toprovide blood glucose data.

Embodiment 11

The reusable accessory of any one of the preceding Embodiments, whereinthe analyte sensor system is a flash glucose monitor adapted to provideglucose data via near field communication.

Embodiment 12

The reusable accessory of any one of the preceding Embodiments, whereinthe analyte sensor system is a continuous glucose monitor adapted toprovide blood data via wireless radio communication (e.g., BLUETOOTH LOWENERGY) and optionally near field communication (NFC).

Embodiment 13

The reusable accessory of any one of the preceding Embodiments, furthercomprising at least one button for enabling and disabling operationalmodes of the reusable accessory, including triggering receipt of analytemeasurement data, changing a display, stopping or snoozing an alarm, ora combination thereof.

Embodiment 14

A diabetes management system comprising: a glucose sensor system adaptedwirelessly transmit blood glucose data; an insulin dosage monitoringdevice adapted to be reversibly connectable to an insulin deliverydevice, the insulin dosage monitoring device comprising a display,memory, and processor, the memory storing insulin therapy dosageparameters, the insulin dosage monitoring device being adapted to detectdeliveries of insulin from the insulin delivery device, the insulindosage monitoring device being adapted to wirelessly receive bloodglucose data from the glucose sensor system, the processor being adaptedto provide insulin dose recommendation based on the stored insulintherapy dosage parameters, the blood glucose data, or a combinationthereof; and a mobile computing device including a processor, the mobilecomputing device being configured to intermittently connect to andreceive the at least one characteristic relating to the insulinmonitoring device, the blood glucose data, or a combination thereof fromthe insulin dosage monitoring device via wireless communication.

Embodiment 15

The system of Embodiment 14, wherein the insulin dosage monitoringdevice comprises a pen cap and the insulin delivery device is an insulininjection pen, wherein the pen cap is adapted to detect deliveries ofinsulin from the insulin injection pen by detecting pen cap cappingevents, which may be inferred to be dosing events.

Embodiment 16

The system of any one of the preceding Embodiments, wherein the insulindosage monitoring device comprises a pen cap and the insulin deliverydevice is an insulin injection pen, wherein the pen cap is adapted todetect an amount of insulin remaining in the insulin injection pen todetermine a timing of, and optionally a dose amount, for each dose.

Embodiment 17

The system of any one of the preceding Embodiments, wherein the insulindosage monitoring device comprises an accessory that can detect themovement of a plunger or associated mechanical elements that move duringan injection of insulin from an insulin injection pen.

Embodiment 18

The system of any one of the preceding Embodiments, wherein the mobilecomputing device is configured to receive data relating to the at leastone characteristic over a selected period of time comprising past datavalues leading up to a substantially present time value.

Embodiment 19

A method of managing medication therapy by a manual medication deliverydevice, comprising: receiving analyte measurement data from an analytesensor system; detecting dosing action events at an accessory configuredto reversibly attach to a manual medication delivery device; storing arecord for each of the one or more dosing action events, wherein therecord comprises a dosing time of a dosing action; and providing one ormore medication dose recommendations responsive to the analytemeasurement data.

Embodiment 20

The method of Embodiment 19, further comprising receiving, over a firstwireless connection, analyte measurement data responsive to the wirelesscommunication interface positioned in proximity to at least a portion ofthe analyte sensor system.

Embodiment 21

The method of any one of the preceding Embodiments, further comprisingcommunicating over a second wireless connection, dosing events, therapyparameters, and analyte measurement data with a mobile computing device.

Embodiment 22

The method of any one of the preceding Embodiments, further comprisingreceiving therapy parameters from the mobile computing device over thesecond wireless connection.

Embodiment 23

The method of any one of the preceding Embodiments, wherein the manualmedication delivery device is a medication injection pen and thereusable accessory is a reusable pen cap for the medication injectionpen, and wherein the dosing action events associated with one or moredosing actions are one or more of capping events and decapping events,and the detection circuitry is configured detect capping events anddecapping events responsive to sensor signals.

Embodiment 24

A smart electronics module integratable with a manual medicationdelivery device, comprising: a wireless communication interface that isconfigured to receive analyte measurement data from an analyte sensorsystem; detection circuitry configured to: detect dosing action events;store a record for each of the one or more dosing actions, wherein therecord comprises a dosing time of the dosing action; and receive analytemeasurement data received from the analyte sensor system; arecommendation system configured to provide one or more medication doserecommendations responsive to the analyte measurement data; and anadapter configured to reversibly couple to a predetermined portion ofthe manual medication delivery device.

Embodiment 25

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose data is aninterstitial fluid glucose level or based on an interstitial fluidglucose level.

Embodiment 26

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose data is ablood glucose level correlated to an interstitial fluid glucose level.

Embodiment 27

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose data is ablood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to user interface for diabetes management systems including flashglucose monitor:

Embodiment 1

A diabetes management system comprising: a flash glucose monitor adaptedto be secured to a person with diabetes (PWD), the flash glucose monitorcomprising: a sensing portion adapted to detect blood glucose data atregular time intervals, the regular time intervals being less than orequal to every 15 minutes; and a wireless communication interfaceadapted to transmit blood glucose data when the wireless communicationinterface is activated by a user, wherein the transmitted blood glucosedata for each wireless communication transmission comprises a bloodglucose data collected over a data transmission window of at least 1hour; and a user interface device comprising: a UI wirelesscommunication interface adapted to receive the transmitted blood glucosedata at irregular intervals governed at least in part by the actions ofthe user; a display comprising a touch screen; and a processor andmemory, the processor being adapted to execute instructions in thememory to display a representation of glucose values comprising: agraphical representation having a time of the day along the bottom ofthe graphical representation and a curve of glucose values for each timeof the day that has been received, wherein a current time of day ispresented on the graphical representation to indicate if there is a gapbetween a most recent glucose value and the current time of day; and asingle numerical value representing a single blood glucose measurementadjacent to the graphical representation; wherein the single numericalvalue is the most recent glucose value when the screen is not beingtouched by a user, wherein the processor and memory are configured tochange the single numerical value to a prior glucose value when a usertouches a portion of the screen corresponding to a prior time of day onthe graphical representation.

Embodiment 2

The diabetes management system of Embodiment 1, wherein the graphicalrepresentation comprises a point indicator that is positioned along thetime axis to correspond to the time of day when the single numericalvalue was detected.

Embodiment 3

The diabetes management system of any one of the preceding Embodiments,wherein the display is configured so that the user can change theposition of the point indicator by pressing the portion of the screencorresponding to position along the time axis at a time prior to themoss recent glucose value.

Embodiment 4

The diabetes management system of any one of the preceding Embodiments,wherein the portion of the screen corresponding to a position along thetime axis is a portion of the screen depicting the time axis.

Embodiment 5

The diabetes management system of any one of the preceding Embodiments,wherein the portion of the screen corresponding to a position along thetime axis is a portion of the screen depicting the curve of glucosevalues.

Embodiment 6

The diabetes management system of any one of the preceding Embodiments,wherein the point indicator must be pressed and slid back along thegraphical representation to move the point indicator.

Embodiment 7

The diabetes management system of any one of the preceding Embodiments,wherein the point indicator moves back along the curve of glucose valuesafter a user stops pressing a portion of the graphical representation.

Embodiment 8

The diabetes management system of any one of the preceding Embodiments,wherein the display further depicts a trend arrow adjacent to the singlenumerical value depicting a rate of change of glucose values at the timeof the single numerical value.

Embodiment 9

The diabetes management system of any one of the preceding Embodiments,further comprising a reusable accessory adapted to be reversibly securedto an insulin injection pen, wherein the reusable accessory comprises anaccessory wireless communication interface adapted to be used by a userto interrogate the flash glucose monitor to receive the blood glucosedata.

Embodiment 10

The diabetes management system of any one of the preceding Embodiments,wherein the accessory wireless communication interface is adapted toautomatically transmit the blood glucose data to the user interfacedevice.

Embodiment 11

The diabetes management system of any one of the preceding Embodiments,wherein the reusable accessory is adapted to detect an event associatedwith an administration of insulin from the insulin injection pen.

Embodiment 12

The diabetes management system of any one of the preceding Embodiments,further comprising displaying an injection indicator along the time axisof the graphical representation for each detected event.

Embodiment 13

The diabetes management system of any one of the preceding Embodimentswherein the injection indicator displays an amount of insulinadministered.

Embodiment 14

The diabetes management system of any one of the preceding Embodiments,wherein the injection indicator displays a type of insulin administered.

Embodiment 15

The diabetes management system of any one of the preceding Embodiments,further comprising a second reusable accessory adapted to be reversiblysecured to a second insulin injection pen, the second insulin injectionpen retaining a second type of insulin, wherein the graphicalrepresentation includes different injection indicators along the timeaxis for each reusable accessory.

Embodiment 16

The diabetes management system of any one of the preceding Embodiments,wherein the reusable accessory is a replacement pen cap and the eventassociated with an administration of insulin from the insulin injectionpen is a capping or decapping of the replacement pen cap from theinsulin injection pen.

Embodiment 17

The diabetes management system of any one of the preceding Embodiments,wherein the reusable accessory comprises an accessory display, theaccessory display depicting a most recent glucose value received fromthe flash glucose monitor.

Embodiment 18

The diabetes management system of any one of the preceding Embodiments,wherein the user interface device is adapted to receive insulin therapysettings and wirelessly communicate the insulin therapy settings to thereusable accessory, wherein the accessory display is adapted to providea recommended insulin dose based on the received insulin therapysettings and a most recent glucose value.

Embodiment 19

The diabetes management system of any one of the preceding Embodiments,further comprising a blood glucose meter is wireless communication withone or more components of the system, wherein the graphicalrepresentation also includes BGM indicators representing blood glucosemeasurements from the blood glucose meter.

Embodiment 20

The diabetes management system of any one of the preceding Embodiments,wherein the single numerical value representing a single blood glucosemeasurement is adapted to depict the blood glucose measurements from theblood glucose meter or glucose values from the flash glucose monitor.

Embodiment 21

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose values are aninterstitial fluid glucose level or based on an interstitial fluidglucose level.

Embodiment 22

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose values are ablood glucose level correlated to an interstitial fluid glucose level.

Embodiment 23

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose values are ablood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to devices, systems, and methods for estimating active medication frominjections:

Embodiment 1

A reusable accessory for a medication injection pen wherein the reusableaccessory is adapted to be reversibly attached to a medication injectionpen, the reusable accessory being configured to detect an eventassociated with an injection of medication from the medication injectionpen and determine a percentage of medication that remains active for theinjection of medication based on a current time and a time of the eventassociated with an injection.

Embodiment 2

The reusable accessory of Embodiment 1, wherein the reusable accessoryis a replacement pen cap adapted to be secured to the medicationinjection pen such that medication cannot be injected into a user whenthe replacement pen cap is secured to the medication injection pen,wherein the event associated with an injection of medication is acapping or decapping event that is detected responsive to capping ordecapping the medication injection pen with the replacement pen cap.

Embodiment 3

The reusable accessory of Embodiment 1 or Embodiment 2, wherein thereusable accessory comprises a display, wherein the display depicts avisual indicator of an amount of active medication remaining as apercentage.

Embodiment 4

The reusable accessory of one of Embodiments 1-3, wherein the reusableaccessory is adapted to determine a dose amount for each detected eventassociated with an injection of medication, wherein the reusableaccessory determines an amount of medication that remains active for aplurality of injections of medication based on a current time and a timeof each of the plurality of injections.

Embodiment 5

The reusable accessory for one of Embodiments 1-3, wherein the reusableaccessory does not detect or determine a dose amount for each detectedevent associated with an injection of medication.

Embodiment 6

The reusable accessory of one of Embodiments 1-5, wherein the medicationinjection pen is an insulin injection pen.

Embodiment 7

The reusable accessory of one of Embodiments 1-6, wherein the reusableaccessory comprises a processor and memory, wherein the memory storesone or more user-specific dosage parameters, wherein the processor isadapted to determine a recommended dose of medication based at least inpart on the user-specific dosage parameters and a calculation of activemedication for one or more prior injections of medication.

Embodiment 8

The reusable accessory of one of Embodiments 1-7, wherein the reusableaccessory comprises a wireless communication interface adapted to sendor receive wireless communications.

Embodiment 9

The reusable accessory of any one of the preceding Embodiments, whereinthe reusable accessory is adapted to receive analyte measurement datafrom an analyte senor system via the wireless communication interface,wherein the reusable accessory is adapted to determine a recommendeddose of medication based at least in part on received analytemeasurement data.

Embodiment 10

The reusable accessory of any one of the preceding Embodiments, whereinthe reusable accessory is adapted to send data regarding the eventassociated with each injection of medication to a mobile computingdevice via the wireless communication.

Embodiment 11

The reusable accessory of any one of the preceding Embodiments, whereinthe reusable accessory is adapted to receive user-specific dosageparameters from a mobile computing device via the wirelesscommunication.

Embodiment 12

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface is configured to receive analytemeasurement data from an analyte sensor system.

Embodiment 13

The reusable accessory of any one of the preceding Embodiments, whereinthe reusable accessory comprises a recommendation system configured toprovide one or more medication dose recommendations responsive to theanalyte measurement data.

Embodiment 14

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface comprise a first wirelessconnection having a first communication range and a second wirelessconnection having a second communication range, wherein the firstwireless connection is between the reusable accessory and an analytesensor system, wherein the second wireless connection is between thereusable accessory and a mobile application on a remote computingdevice, wherein the second communication range is greater than the firstcommunication range.

Embodiment 15

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface comprises an NFC chip and the firstwireless connection consists of NFC communications between the reusableaccessory and the analyte sensor system.

Embodiment 16

The reusable accessory of any one of the preceding Embodiments, whereinthe wireless communication interface comprises a wireless radio adaptedto permit BLUETOOTH Low Energy communications between the reusableaccessory and one or more mobile computing devices.

Embodiment 17

The reusable accessory of any one of the preceding Embodiments, whereinthe analyte sensor system is a flash glucose monitor adapted to provideglucose data via near field communication.

Embodiment 18

A diabetes therapy management system comprising: a mobile computingdevice being adapted to receive one or more user-specific dosageparameters or predetermined doses from a user; a glucose sensor systemadapted to collect and wirelessly transmit blood glucose data; andreusable accessory adapted to be reversibly attached to an insulininjection pen, the reusable accessory comprising: a wirelesscommunication interface adapted to receive the blood glucose data fromthe glucose sensor system and the one or more user-specific dosageparameters or predetermined doses from the mobile computing device; aninjection detection mechanism adapted to detect an event associated withan injection of insulin; a processor to determine a percentage ofinsulin that remains active for each injection of insulin; and a displayadapted to display an amount of active insulin remaining in the user asa percentage of the last injection of insulin.

Embodiment 19

The system of Embodiment 18, wherein the reusable accessory detects ordetermines a dose of insulin for each event associated with an injectionof insulin and the display displays an amount of active insulinremaining in the user as a number of units of insulin, which canoptionally include multiple doses of insulin at different times.

Embodiment 20

The system of any one of the preceding Embodiments, wherein the reusableaccessory does not detect or determines a dose of insulin for each eventassociated with an injection of insulin.

Embodiment 21

A method of managing a diabetes therapy, comprising: detecting an eventassociated with an injection of medication from a medication injectionpen responsive to an attaching or detaching of a reusable accessory tothe medication injection pen; determining a percentage of medicationthat remains active for the injection of medication based on a currenttime and time of the event associated with the injection, wherein theevent is associated with attaching or detaching a reusable accessory tothe medication injection pen.

Embodiment 22

A smart electronics module integratable with a medication injection penwherein the reusable accessory is adapted to be reversibly attached to amedication injection pen, the reusable accessory being configured todetect an event associated with an injection of medication from themedication injection pen and determine a percentage of medication thatremains active for the injection of medication based on a current timeand a time of the event associated with an injection.

Embodiment 23

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose data is aninterstitial fluid glucose level or based on an interstitial fluidglucose level.

Embodiment 24

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose data is ablood glucose level correlated to an interstitial fluid glucose level.

Embodiment 25

A system, method or device according to any one of the precedingembodiments, wherein the blood glucose data and/or glucose data is ablood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to insulin injection assistance systems, methods, and devices:

Embodiment 1

A system to assist with the manual dosing of insulin, the systemcomprising: at least a first glucose sensor system adapted to wirelesslytransmit glucose data; at least a first reusable insulin dosing detectoradapted to be reversibly connectable to at least a first disposablecomponent comprising a chamber for a first insulin type to form at leastpart of a first insulin manual delivery assembly, the first reusableinsulin dosing detector configured to detect first insulin deliveryevents associated with the first insulin manual delivery assembly, and arecommendation system comprising a mobile application and a computingdevice remote from the first reusable insulin dosing detector, whereinthe mobile application, while executing at the computing device, isconfigured to: receive insulin therapy settings, the insulin therapysettings comprising a first insulin type setting; determine first timingdata corresponding to one or more first insulin delivery event times ofone or more of the first insulin delivery events; analyze the glucosedata in combination with the first timing data; and determine anadjustment recommendation or automatic insulin therapy setting changeresponsive to the analysis.

Embodiment 2

The system of Embodiment 1, further comprising a remote server adaptedto receive the glucose data and the first timing data over an interneconnection between the mobile computing device and the remote server.

Embodiment 3

The system of any one of the preceding Embodiments, wherein the remoteserver is configured to analyze the first timing data and the glucosedata, and determine the adjustment recommendation or the automaticinsulin therapy setting change responsive to the analysis.

Embodiment 4

The system of any one of the preceding Embodiments, wherein the mobileapplication is configured to analyze the first timing data and theglucose data, determine the adjustment recommendation or the automaticinsulin therapy setting change responsive to the analysis.

Embodiment 5

The system of any one of the preceding Embodiments, wherein the firstreusable insulin dosing detector is a first reusable accessory, thefirst disposable component is a first insulin injection pen or a firstinsulin inhaler, and the first insulin delivery events are associateinsulin injection or insulin inhalation, and wherein the first reusableaccessory is adapted to reversibly connect to the first insulininjection pen or the first insulin inhaler.

Embodiment 6

The system of any one of the preceding Embodiments, wherein the firstreusable accessory is a first replacement cap adapted to be placed overa needle of the first insulin injection pen or adapted to be placed overan inhalation pathway of the first insulin inhaler, wherein the firstreplacement cap is configured to detect capping and/or de-cappingevents.

Embodiment 7

The system of any one of the preceding Embodiments, wherein the firstreusable accessory is configured to detect the first insulin deliveryevents responsive to the one or more capping and/or de-capping events.

Embodiment 8

The system of any one of the preceding Embodiments, wherein the firstreusable insulin dosing detector is a first reusable smart pen or afirst smart inhaler and the first disposable component comprises a firstinsulin cartridge, wherein the first reusable smart pen or the firstsmart inhaler is configured to receive the first insulin injectioncartridge and configured to be actuated by a user to deliver the firstinsulin type from the first insulin cartridge.

Embodiment 9

The system of any one of the preceding Embodiments, further comprising:at least a second reusable insulin dosing detector adapted to bereversibly connectable to a second disposable component comprising achamber for a second insulin type to form at least part of a secondinsulin manual delivery assembly, wherein the second reusable accessorycomprises a second wireless communication interface configured towirelessly receive a second insulin type setting of the insulin deliverysettings from the mobile application, wherein the second reusableinsulin dosing detector configured to detect second insulin deliveryevents associated with the second insulin manual delivery assembly, andwherein the recommendation system is configured to: determine secondtiming data corresponding to one or more second insulin delivery eventtimes for one or more second insulin delivery events; analyze theglucose data in combination with the first timing data and the secondtiming data; and determine an adjustment recommendation or automaticchange to an insulin delivery setting responsive to the analysis.

Embodiment 10

The system of any one of the preceding Embodiments, wherein the secondreusable insulin dosing detector is configured to wirelessly receiveglucose data from the first glucose sensor system.

Embodiment 11

The system of any one of the preceding Embodiments, wherein the systemdisables the wireless communication of the glucose data from the firstglucose sensor system to the first reusable insulin dosing detectorwhile the first glucose sensor system is in wireless communication withthe second reusable insulin dosing detector.

Embodiment 12

The system of any one of the preceding Embodiments, wherein the secondreusable insulin dosing detector is selected from the group consistingof a second smart pen configured to receive a second disposable pencartridge containing a second insulin type, a second smart inhalerconfigured to receive a second disposable inhalable insulin cartridgecontaining a second insulin type, a second replacement pen cap adaptedto be secured over a needle of a second disposable insulin injection pencontaining the second insulin type, or a second replacement inhaler capadapted to be secured over an inhalation pathway of an second insulininhaler.

Embodiment 13

The system of any one of the preceding Embodiments, wherein the firstinsulin type is selected from a group consisting of a long actinginsulin, a rapid acting insulin, and a combination long acting and rapidacting insulin.

Embodiment 14

The system of any one of the preceding Embodiments, wherein the firstglucose sensor system is a blood glucose meter adapted to analyze bloodin vitro.

Embodiment 15

The system of any one of the preceding Embodiments, wherein therecommendation system is adapted to analyze the timing data of one ormore insulin delivery events and the glucose data to recommend adding asecond glucose sensor system selected from the group consisting ofcontinuous glucose monitors and flash glucose monitors.

Embodiment 16

The system of any one of the preceding Embodiments, wherein the firstglucose sensor system is a flash glucose monitor.

Embodiment 17

The system of any one of the preceding Embodiments, wherein the firstglucose sensor system is configured to communicate a limited glucosedata set to the mobile application via a first communication techniquehaving a first communication range and to communicate robust glucosedata set to the first or second reusable insulin dosing detector via asecond communication technique having a second communication range, thefirst communication range being greater than the second communicationrange.

Embodiment 18

The system of any one of the preceding Embodiments, wherein the mobileapplication can receive glucose data directly from the first glucosesensor system via the first communication technique and the secondcommunication technique.

Embodiment 19

The system of any one of the preceding Embodiments, wherein the firstreusable insulin dosing detector comprises a display, wherein thedisplay is configured to provide a recommended first insulin dose of thefirst insulin type based on the first insulin setting.

Embodiment 20

The system of any one of the preceding Embodiments, wherein the firstreusable insulin dosing detector or the mobile application is configuredto issue an alert if a detected dose of the first insulin type fails tocomply with the first insulin setting.

Embodiment 21

The system of any one of the preceding Embodiments, wherein the systemis adapted to determine one or more insulin dose amounts of the firstinsulin type associated with each detected first insulin delivery event.

Embodiment 22

A method of assisted manual dosing of insulin, the method comprising:receiving first insulin delivery events associated with a first insulinmanual delivery assembly, the first insulin manual delivery assemblycomprising a first reusable insulin dosing detector reversibly connectedto a first disposable component and adapted to detect the first insulindelivery events; determining first timing data corresponding to one ormore first insulin delivery event times of one or more of the firstinsulin delivery events; analyzing the glucose data in combination withthe first timing data; and determining an adjustment recommendation oran automatic insulin therapy setting change responsive to the analysis.

Embodiment 23

The method of Embodiment 22, further comprising receiving the firstinsulin delivery events at a communication interface configured forwireless communication with the first reusable insulin dosing detector.

Embodiment 24

The method of any one of the preceding Embodiments, further comprising:receiving second insulin delivery events associated with a secondinsulin manual delivery assembly, the second insulin manual deliveryassembly comprising a second reusable insulin dosing detector reversiblyconnected to a second disposable component and adapted to detect thesecond insulin delivery events; and determining a second adjustmentrecommendation or a second automatic insulin therapy setting changeresponsive to the second insulin delivery events.

Embodiment 25

The method of any one of the preceding Embodiments, further comprisingreceiving glucose data from the first reusable dosing detector.

Embodiment 26

The method of any one of the preceding Embodiments, further comprisingreceiving glucose data from a first glucose sensor system.

Embodiment 27

A system for remotely assigning with the manual dosing of insulin, thesystem comprising: receiving first insulin delivery events associatedwith a first insulin manual delivery assembly, wherein the insulindelivery events are received at a communication interface configured forcommunication with a reusable insulin dosing detector; determining firsttiming data corresponding to one or more first insulin delivery eventtimes for one or more first insulin delivery events; analyzing theglucose data in combination with the first timing data; determining anadjustment recommendation or an automatic insulin therapy setting changeresponsive to the analysis; and providing the adjustment recommendationor the automatic insulin therapy setting change to the communicationinterface to send to the reusable insulin dosing detector.

Embodiment 28

An insulin manual dosing assistance system, the system comprising: arecommendation system comprising a mobile application executing at acomputing device, the mobile application configured to determine insulindelivery adjustment recommendations and insulin therapy setting changesresponsive to glucose data associated with one or more insulin deliveryevents, the recommendation system further configured to: detect a firstreusable insulin dosing detector; create an insulin manual deliveryassembly profile responsive to the detection, the insulin manualdelivery assembly profile associated with an insulin manual deliveryassembly of the first reusable insulin dosing detector; and assign oneor more insulin therapy settings to the insulin manual delivery assemblyprofile.

Embodiment 29

The system of Embodiment 28, wherein the recommendation system isconfigured to, responsive to one or more physiological parametersassociated with a user of the recommendation system, either load the oneor more insulin therapy settings from memory, or create the one or moreinsulin therapy settings.

Embodiment 30

The system of any one of the preceding Embodiments, wherein therecommendation system is configured to provide a user prompt at adisplay of the computing device, the user prompt comprising one anapproval for pairing with the first reusable insulin dosing detector.

Embodiment 31

The system of any one of the preceding Embodiments, wherein therecommendation system is configured to send one or more of insulindelivery adjustment recommendations and changes to insulin therapysetting to the reusable insulin dosing detector.

Embodiment 32

The system of any one of the preceding Embodiments, wherein therecommendation system is further configured to receive an instruction toun-pair with a second insulin dosing detector, and, responsive to theinstruction to un-pair, delete or deactivate a second insulin manualdelivery assembly profile associated with the second insulin dosingdetector.

Embodiment 33

The system of any one of the preceding Embodiments, wherein therecommendation system is further configured to: detect a second reusableinsulin dosing detector; create a second insulin manual deliveryassembly profile responsive to the detection, the second insulin manualdelivery assembly profile associated with a second insulin manualdelivery assembly of the second reusable insulin dosing detector; andassign one or more second insulin therapy settings to the second insulinmanual delivery assembly profile.

Embodiment 34

The system of any one of the preceding Embodiments, wherein therecommendation system is configured to send insulin delivery adjustmentrecommendations and insulin therapy setting changes to the first and thesecond reusable insulin dosing detector.

Embodiment 35

The system of any one of the preceding Embodiments, wherein therecommendation system is configured to receive glucose data associatedwith one or more insulin delivery events of the first and the secondreusable insulin dosing detector.

Embodiment 36

The system of any one of the preceding Embodiments, wherein the firstreusable insulin dosing detector and the second reusable insulin dosingdetector is each a different one of a reusable accessory, a smartinsulin pen, and a smart insulin.

Embodiment 37

A system to assist with the manual dosing of insulin, the systemcomprising: at least a first glucose sensor system adapted to wirelesslytransmit glucose data; smart electronics coupled with one or more partsof a first insulin manual delivery assembly, the smart electronicscomprising at least a first reusable insulin dosing detector operablyconnected to at least a first disposable component comprising a chamberfor a first insulin type to form at least part of the first insulinmanual delivery assembly, the first reusable insulin dosing detectorconfigured to detect first insulin delivery events associated with thefirst insulin manual delivery assembly; and a recommendation systemcomprising a mobile application and a computing device remote from thefirst reusable insulin dosing detector, wherein the mobile application,while executing at the computing device, is configured to: receiveinsulin therapy settings, the insulin therapy settings comprising afirst insulin type setting; determine first timing data corresponding toone or more first insulin delivery event times for one or more firstinsulin delivery events; analyze the glucose data in combination withthe first timing data; and determine an adjustment recommendation orautomatic insulin therapy setting change responsive to the analysis.

Embodiment 38

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is an interstitial fluid glucoselevel or based on an interstitial fluid glucose level.

Embodiment 39

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose levelcorrelated to an interstitial fluid glucose level.

Embodiment 40

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to pen cap for medication injection pen having temperature sensor:

Embodiment 1

A replacement pen cap for a medication injection pen comprising at leastone temperature sensor, wherein the at least one temperature sensor isconfigured to monitor a temperature of medication within the medicationinjection pen while the replacement pen cap is associated with themedication injection pen, wherein the replacement pen cap is adapted todetect possible dosing events, wherein the replacement pen cap isadapted to receive analyte measurement data from an analyte sensorsystem, wherein the replacement pen cap is adapted to determine ifmedication in the medication injection pen is denatured based on acombination of data from the at least one temperature sensor and thereceived analyte measurement data subsequent to each detected possibledosing event.

Embodiment 2

The replacement pen cap of Embodiment 1, wherein the at least onetemperature sensor is configured to monitor ranges of temperature whenthe pen cap is associated with the insulin pen.

Embodiment 3

The replacement pen cap of any one of the preceding Embodiments, whereinthe pen cap is configured to provide at least one of an alarm or alertto a user when a selected threshold temperature value is sensed, whereinan alert is presented when a threshold is exceeded as a visual displayand an audible alarm is triggered when the threshold is exceeded and thepen cap receives glucose values that indicate that one or more priorinsulin administrations have been ineffective.

Embodiment 4

The pen cap of any one of the preceding Embodiments, wherein the pen capis configured to provide data to a user relating to the temperatureexposure of the insulin.

Embodiment 5

A smart electronics module integratable with a medication injection pencomprising at least one temperature sensor, wherein the at least onetemperature sensor is configured to monitor a temperature of medicationwithin the medication injection pen while the smart electronics moduleis enabled, wherein the smart electronics module is configured to detectpossible dosing events, wherein the smart electronics module isconfigured to receive analyte measurement data from an analyte sensorsystem, wherein the smart electronics module is configured to determineif medication in the medication injection pen is denatured based on acombination of data from the at least one temperature sensor and thereceived analyte measurement data subsequent to each detected possibledosing event.

Embodiment 6

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is an interstitial fluid glucoselevel or based on an interstitial fluid glucose level.

Embodiment 7

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose levelcorrelated to an interstitial fluid glucose level.

Embodiment 8

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to user interface for diabetes management systems and devices:

Embodiment 1

A diabetes management system comprising: a computing device includingmemory and a processor configured to: receive at least one data pointrelating to prior insulin use of a subject; and calculate a slidingscale glucose correction data set based, at least in part, on the atleast one data point relating to prior insulin use of a subject.

Embodiment 2

The system of Embodiment 1, further comprising an insulin pen assembly,wherein the computing device is configured to provide at least some datafrom the sliding scale glucose correction data set to the insulin penassembly, and wherein the insulin pen assembly is configured to displaythe at least some data as a recommended correction insulin dose.

Embodiment 3

The system of any one of the preceding Embodiments, wherein the insulinpen assembly comprises a reusable accessory for an insulin pen and adisposable insulin pen.

Embodiment 4

The system of any one of the preceding Embodiments, wherein the reusableaccessory is a replacement pen cap for the disposable insulin pen.

Embodiment 5

The system of any one of the preceding Embodiments, wherein the insulinpen assembly is a reusable insulin injection pen adapted to receiveprefilled insulin cartridges for administering insulin.

Embodiment 6

The system of any one of the preceding Embodiments, wherein the insulinpen assembly is adapted to receive blood glucose data from a glucosesensor system, wherein the recommended correction insulin dose is basedon the received blood glucose data and that sliding scale glucosecorrection data set.

Embodiment 7

The system of any one of the preceding Embodiments, wherein the slidingscale glucose correction data set is a linear scale based on the atleast one data point comprising an insulin sensitivity factor.

Embodiment 8

The system of any one of the preceding Embodiments, wherein the slidingscale glucose correction data set is a nonlinear scale based on the atleast one data point comprising a plurality of data points inputted intothe computing device.

Embodiment 9

The system of any one of the preceding Embodiments, wherein theplurality of data points each comprises a range of glucose values and anassociated correction dose.

Embodiment 10

The system of any one of the preceding Embodiments, wherein the range ofglucose values and the associated correction dose are based onhistorical insulin use of a subject.

Embodiment 11

A diabetes management system comprising: a computing device includingmemory and a processor configured to: display a plurality of pictures ofmeals grouped into a plurality of categories, each category having asimilar glycemic impact; and receive a user input of a number of unitsof insulin that the user would normally administer for meals in thatcategory for each of the plurality of categories; and an insulin penassembly having a pen display, wherein the computing device isconfigured to provide the insulin pen assembly with the user inputs foreach category, the pen display providing at least one recommendedinsulin dose based at least in part on the received user inputs for eachcategory.

Embodiment 12

The system of Embodiment 11, wherein the insulin pen assembly displays arecommended insulin dose for each of the plurality of categories.

Embodiment 13

The system of any one of the preceding Embodiments, wherein thecomputing device receives user input defining a correction factor basedon blood glucose levels, wherein the insulin pen assembly is adapted toreceive blood glucose data from a glucose sensor system, wherein theinsulin pen assembly receives the correction factor from the computingdevice, wherein each recommended insulin dose is based upon thecorrection factor and the blood glucose data.

Embodiment 14

The system of any one of the preceding Embodiments, wherein correctionfactor is a sliding scale glucose correction data set.

Embodiment 15

The system of any one of the preceding Embodiments, wherein the insulinpen assembly comprises a reusable accessory for an insulin pen and adisposable insulin pen.

Embodiment 16

The system of any one of the preceding Embodiments, wherein the reusableaccessory is a replacement pen cap for the disposable insulin pen.

Embodiment 17

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is an interstitial fluid glucoselevel or based on an interstitial fluid glucose level.

Embodiment 18

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose levelcorrelated to an interstitial fluid glucose level.

Embodiment 19

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose level.

Additional non-limiting embodiments of the disclosure relate, generally,to alarms and alerts in diabetes management system:

Embodiment 1

A diabetes management system comprising: one or more signaling outputsconfigured to present one or more of alarms, alerts, and notificationsdiscernable by a user; at least a first glucose sensor system adapted towirelessly transmit glucose data via at least a first wirelesscommunication method having a first communication range and a secondwireless communication method having a second communication range,wherein the first wireless communication method requires user action andthe second wireless communication method is automatic, wherein thesecond communication range is greater than the first communicationrange; at least a first reusable accessory adapted to be reversiblyconnectable to at least a first insulin injection pen, the firstreusable accessory being adapted to wirelessly receive the glucose datafrom the first glucose sensor system via the first wirelesscommunication method upon being moved through the first communicationrange; and a mobile application on a remote computing device adapted toreceive glucose data automatically via the second wireless communicationmethod, the mobile application issuing an alarm at the one or moresignaling outputs responsive, at least in part, to the received glucosedata.

Embodiment 2

The diabetes management system of Embodiment 1, further comprising aninsulin type detector configured to detect a type of insulin in achamber of an insulin manual delivery device, wherein the first reusableaccessory is configured to issue an alarm at the one or more signalingoutputs responsive to the detector, the alarm indicating an incorrectinsulin type.

Embodiment 3

The diabetes managing system of any one of the preceding Embodiments,further comprising an insulin type detector configured to detect a typeof insulin in a chamber of an insulin manual delivery device, whereinthe mobile application is configured to issue an alarm at the one ormore signaling outputs responsive to the detector, the alarm indicatingan incorrect insulin type.

Embodiment 4

The diabetes management system of any one of the preceding Embodiments,wherein the mobile application is configured to compare a detectedinsulin type to an expected insulin type and output an error signalresponsive to the comparison.

Embodiment 5

The diabetes management system of any one of the preceding Embodiments,wherein the mobile application is configured to determine an expectedinsulin type responsive to dosing action or based on a user providedparameter.

Embodiment 6

The diabetes management system of any one of the preceding Embodiments,further comprising a user confirmation system configured to present aprompt to a user responsive to dosing actions and one or more diabetesmanagement system mode.

Embodiment 7

The diabetes management system of any one of the preceding Embodiments,wherein the user confirmation system is configured to present a promptfor physiological parameters responsive to a hyper system monitoringmode and a high correction dose associated with a recent dosing action.

Embodiment 8

The diabetes management system of any one of the preceding Embodiments,further comprising a user confirmation system configured to present aprompt for glucose measurements responsive to a current time or a timeperiod.

Embodiment 9

The diabetes management system of any one of the preceding Embodiments,wherein the first reusable accessory does not receive glucose data viathe first wireless communication method from the first glucose sensorsystem.

Embodiment 10

The diabetes management system of any one of the preceding Embodiments,wherein the first reusable accessory is adapted to receive glucose datafrom the mobile application via the second wireless communicationmethod.

Embodiment 11

The diabetes management system of any one of the preceding Embodiments,wherein the first communication method is near field communication andthe second communication method is BLUETOOTH low energy.

Embodiment 12

The diabetes management system of any one of the preceding Embodiments,wherein the alarm is based on a received glucose value being less than athreshold.

Embodiment 13

The diabetes management system of any one of the preceding Embodiments,wherein the alarm is based on a predicted future glucose value beingless than a threshold.

Embodiment 14

The diabetes management system of any one of the preceding Embodiments,wherein the first accessory is adapted to detect the administration ofinsulin from the first insulin injection pen and communicateadministration data to the mobile application via the second wirelesscommunication method.

Embodiment 15

The diabetes management system of any one of the preceding Embodiments,wherein the alarm is based at least in part on the administration data.

Embodiment 16

The diabetes management system of any one of the preceding Embodiments,wherein the first insulin injection pen is a long-acting insulininjection pen and the alarm is a missed dose alarm.

Embodiment 17

The diabetes management system of any one of the preceding Embodiments,wherein the alarm is responsive to a high correction dose, a detecteddosing event, and a time out.

Embodiment 18

The diabetes management system of any one of the preceding Embodiments,wherein the alarm is responsive to a missed dosing event, a highcorrection dose, and a time out.

Embodiment 19

A diabetes management system comprising: one or more signaling outputsconfigured to present one or more of alarms, alerts, and notificationsdiscernable by a user; at least a first glucose sensor system adapted towirelessly transmit glucose data via at least a first wirelesscommunication method having a first communication range and a secondwireless communication method having a second communication range,wherein the first wireless communication method requires user action andthe second wireless communication method is automatic, wherein thesecond communication range is greater than the first communicationrange; at least a first smart electronics module configured to beintegratable with a first insulin injection pen, the first smartelectronics module being configured to wirelessly receive the glucosedata from the first glucose sensor system via the first wirelesscommunication method upon being moved through the first communicationrange; and a mobile application on a remote computing device adapted toreceive glucose data automatically via the second wireless communicationmethod, the mobile application issuing an alarm at the one or moresignaling outputs responsive, at least in part, to the received glucosedata.

Embodiment 20

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is an interstitial fluid glucoselevel or based on an interstitial fluid glucose level.

Embodiment 21

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose levelcorrelated to an interstitial fluid glucose level.

Embodiment 22

A system, method or device according to any one of the precedingembodiments, wherein the glucose data is a blood glucose level.

What is claimed is:
 1. A system to assist with manual dosing of insulin,the system comprising: at least a first glucose sensor system adapted towirelessly transmit glucose data; at least a first reusable insulindosing detector adapted to be reversibly connectable to at least a firstdisposable component comprising a chamber for a first insulin type toform at least part of a first insulin manual delivery assembly, thefirst reusable insulin dosing detector configured to detect firstinsulin delivery events associated with the first insulin manualdelivery assembly, and a recommendation system comprising a mobileapplication and a computing device remote from the first reusableinsulin dosing detector, wherein the mobile application, while executingat the computing device, is configured to: receive insulin therapysettings, the insulin therapy settings comprising a first insulin typesetting; determine first timing data corresponding to one or more firstinsulin delivery event times of one or more of the first insulindelivery events; analyze the glucose data in combination with the firsttiming data; and determine an adjustment recommendation responsive tothe analysis.
 2. The system of claim 1, further comprising a remoteserver adapted to receive the glucose data and the first timing dataover an internet connection between the mobile application, thecomputing device and the remote server.
 3. The system of claim 2,wherein the remote server is configured to analyze the first timing dataand the glucose data, and determine the adjustment recommendationresponsive to the analysis.
 4. The system of claim 1, wherein the mobileapplication is configured to analyze the first timing data and theglucose data, determine the adjustment recommendation responsive to theanalysis.
 5. The system of claim 1, wherein the first reusable insulindosing detector is a first reusable accessory, the first disposablecomponent is a first insulin injection pen or a first insulin inhaler,and the first insulin delivery events are associate insulin injection orinsulin inhalation, and wherein the first reusable accessory is adaptedto reversibly connect to the first insulin injection pen or the firstinsulin inhaler.
 6. The system of claim 5, wherein the first reusableaccessory is a first replacement cap adapted to be placed over a needleof the first insulin injection pen or adapted to be placed over aninhalation pathway of the first insulin inhaler, wherein the firstreplacement cap is configured to detect one or more capping and/orde-capping events.
 7. The system of claim 6, wherein the first reusableaccessory is configured to detect the first insulin delivery eventsresponsive to the one or more capping and/or de-capping events.
 8. Thesystem of claim 1, wherein the first reusable insulin dosing detector isa first reusable smart pen or a first smart inhaler and the firstdisposable component comprises a first insulin cartridge, wherein thefirst reusable smart pen or the first smart inhaler is configured toreceive the first insulin cartridge and configured to be actuated by auser to deliver the first insulin type from the first insulin cartridge.9. The system of claim 1, further comprising: at least a second reusableinsulin dosing detector adapted to be reversibly connectable to a seconddisposable component comprising a chamber for a second insulin type toform at least part of a second insulin manual delivery assembly, whereinthe at least a second reusable insulin dosing detector comprises asecond wireless communication interface configured to wirelessly receivea second insulin type setting of the insulin delivery settings from themobile application, wherein the at least a second reusable insulindosing detector configured to detect second insulin delivery eventsassociated with the second insulin manual delivery assembly, and whereinthe recommendation system is configured to: determine second timing datacorresponding to one or more second insulin delivery event times for oneor more second insulin delivery events; analyze the glucose data incombination with the first timing data and the second timing data; anddetermine an adjustment recommendation responsive to the analysis. 10.The system of claim 9, wherein the second reusable insulin dosingdetector is configured to wirelessly receive glucose data from the firstglucose sensor system.
 11. The system of claim 10, wherein the systemdisables the wireless communication of the glucose data from the firstglucose sensor system to the first reusable insulin dosing detectorwhile the first glucose sensor system is in wireless communication withthe second reusable insulin dosing detector.
 12. The system of claim 9,wherein the second reusable insulin dosing detector is selected from thegroup consisting of a second smart pen configured to receive a seconddisposable pen cartridge containing a second insulin type, a secondsmart inhaler configured to receive a second disposable inhalableinsulin cartridge containing a second insulin type, a second replacementpen cap adapted to be secured over a needle of a second disposableinsulin injection pen containing the second insulin type, or a secondreplacement inhaler cap adapted to be secured over an inhalation pathwayof an second insulin inhaler.
 13. The system of claim 9, wherein thefirst insulin type is selected from a group consisting of a long actinginsulin, a rapid acting insulin, and a combination long acting and rapidacting insulin.
 14. The system of claim 1, wherein the first glucosesensor system is a glucose meter adapted to analyze blood in vitro. 15.The system of claim 14, wherein the recommendation system is adapted toanalyze the timing data of one or more first insulin delivery eventtimes and blood glucose data to recommend adding a second glucose sensorsystem selected from the group consisting of continuous glucose monitorsand flash glucose monitors.
 16. The system of claim 1, wherein the firstglucose sensor system is a flash glucose monitor.
 17. The system ofclaim 9, wherein the first glucose sensor system is configured tocommunicate a limited glucose data set to the mobile application via afirst communication technique having a first communication range and tocommunicate robust glucose data set to the first or second reusableinsulin dosing detector via a second communication technique having asecond communication range, the first communication range being greaterthan the second communication range.
 18. The system of claim 17, whereinthe mobile application can receive glucose data directly from the firstglucose sensor system via the first communication technique and thesecond communication technique.
 19. The system of claim 1, wherein thefirst reusable insulin dosing detector comprises a display, wherein thedisplay is configured to provide a recommended first insulin dose of thefirst insulin type based on the first insulin type setting.
 20. Thesystem of claim 1, wherein the first reusable insulin dosing detector orthe mobile application is configured to issue an alert if a detecteddose of the first insulin type fails to comply with the first insulintype setting.
 21. The system of claim 1, wherein the system is adaptedto determine one or more insulin dose amounts of the first insulin typeassociated with each detected first insulin delivery event.
 22. A systemto assist with manual dosing of insulin, the system comprising: at leasta first glucose sensor system adapted to wirelessly transmit glucosedata; smart electronics coupled with one or more parts of a firstinsulin manual delivery assembly, the smart electronics comprising atleast a first reusable insulin dosing detector operably connected to atleast a first disposable component comprising a chamber for a firstinsulin type to form at least part of the first insulin manual deliveryassembly, the first reusable insulin dosing detector configured todetect first insulin delivery events associated with the first insulinmanual delivery assembly; and a recommendation system comprising amobile application and a computing device remote from the first reusableinsulin dosing detector, wherein the mobile application, while executingat the computing device, is configured to: receive insulin therapysettings, the insulin therapy settings comprising a first insulin typesetting; determine first timing data corresponding to one or more firstinsulin delivery event times for one or more first insulin deliveryevents; analyze the glucose data in combination with the first timingdata; and determine an adjustment recommendation responsive to theanalysis.
 23. The system of claim 22, wherein the glucose data is aninterstitial fluid glucose level or based on an interstitial fluidglucose level.
 24. The system of claim 22, wherein the glucose data is aglucose level correlated to an interstitial fluid glucose level.
 25. Thesystem of claim 22, wherein the glucose data is a glucose level.